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2. Additional file 9 of Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3): a randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery
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Marcucci, Maura, Painter, Thomas W., Conen, David, Leslie, Kate, Lomivorotov, Vladimir V., Sessler, Daniel, Chan, Matthew T. V., Borges, Flavia K., Mart��nez Zapata, Maria J., Wang, C. Y., Xavier, Denis, Ofori, Sandra N., Landoni, Giovanni, Efremov, Sergey, Kleinlugtenbelt, Ydo V., Szczeklik, Wojciech, Schmartz, Denis, Garg, Amit X., Short, Timothy G., Wittmann, Maria, Meyhoff, Christian S., Amir, Mohammed, Torres, David, Patel, Ameen, Duceppe, Emmanuelle, Ruetzler, Kurtz, Parlow, Joel L., Tandon, Vikas, Wang, Michael K., Fleischmann, Edith, Polanczyk, Carisi A., Jayaram, Raja, Astrakov, Sergey V., Rao, Mangala, VanHelder, Tomas, Wu, William K. K., Cheong, Chao Chia, Ayad, Sabry, Abubakirov, Marat, Kirov, Mikhail, Bhatt, Keyur, de Nadal, Miriam, Likhvantsev, Valery, Iglesisas, Pilar Paniagua, Aguado, Hector J., McGillion, Michael, Lamy, Andre, Whitlock, Richard P., Roshanov, Pavel, Stillo, David, Copland, Ingrid, Vincent, Jessica, Balasubramanian, Kumar, Bangdiwala, Shrikant I., Biccard, Bruce, Kurz, Andrea, Srinathan, Sadeesh, Petit, Shirley, Eikelboom, John, Richards, Toby, Gross, Peter L., Alfonsi, Pascal, Guyatt, Gordon, Belley-Cote, Emily, Spence, Jessica, McIntyre, William, Yusuf, Salim, and Devereaux, P. J.
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Additional file 9. POISE-3 informed consent form template (English).
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- 2022
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3. Additional file 7 of Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3): a randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery
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Marcucci, Maura, Painter, Thomas W., Conen, David, Leslie, Kate, Lomivorotov, Vladimir V., Sessler, Daniel, Chan, Matthew T. V., Borges, Flavia K., Mart��nez Zapata, Maria J., Wang, C. Y., Xavier, Denis, Ofori, Sandra N., Landoni, Giovanni, Efremov, Sergey, Kleinlugtenbelt, Ydo V., Szczeklik, Wojciech, Schmartz, Denis, Garg, Amit X., Short, Timothy G., Wittmann, Maria, Meyhoff, Christian S., Amir, Mohammed, Torres, David, Patel, Ameen, Duceppe, Emmanuelle, Ruetzler, Kurtz, Parlow, Joel L., Tandon, Vikas, Wang, Michael K., Fleischmann, Edith, Polanczyk, Carisi A., Jayaram, Raja, Astrakov, Sergey V., Rao, Mangala, VanHelder, Tomas, Wu, William K. K., Cheong, Chao Chia, Ayad, Sabry, Abubakirov, Marat, Kirov, Mikhail, Bhatt, Keyur, de Nadal, Miriam, Likhvantsev, Valery, Iglesisas, Pilar Paniagua, Aguado, Hector J., McGillion, Michael, Lamy, Andre, Whitlock, Richard P., Roshanov, Pavel, Stillo, David, Copland, Ingrid, Vincent, Jessica, Balasubramanian, Kumar, Bangdiwala, Shrikant I., Biccard, Bruce, Kurz, Andrea, Srinathan, Sadeesh, Petit, Shirley, Eikelboom, John, Richards, Toby, Gross, Peter L., Alfonsi, Pascal, Guyatt, Gordon, Belley-Cote, Emily, Spence, Jessica, McIntyre, William, Yusuf, Salim, and Devereaux, P. J.
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Additional file 7. POISE-3 interim analyses.
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- 2022
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4. Additional file 10 of Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3): a randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery
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Marcucci, Maura, Painter, Thomas W., Conen, David, Leslie, Kate, Lomivorotov, Vladimir V., Sessler, Daniel, Chan, Matthew T. V., Borges, Flavia K., Mart��nez Zapata, Maria J., Wang, C. Y., Xavier, Denis, Ofori, Sandra N., Landoni, Giovanni, Efremov, Sergey, Kleinlugtenbelt, Ydo V., Szczeklik, Wojciech, Schmartz, Denis, Garg, Amit X., Short, Timothy G., Wittmann, Maria, Meyhoff, Christian S., Amir, Mohammed, Torres, David, Patel, Ameen, Duceppe, Emmanuelle, Ruetzler, Kurtz, Parlow, Joel L., Tandon, Vikas, Wang, Michael K., Fleischmann, Edith, Polanczyk, Carisi A., Jayaram, Raja, Astrakov, Sergey V., Rao, Mangala, VanHelder, Tomas, Wu, William K. K., Cheong, Chao Chia, Ayad, Sabry, Abubakirov, Marat, Kirov, Mikhail, Bhatt, Keyur, de Nadal, Miriam, Likhvantsev, Valery, Iglesisas, Pilar Paniagua, Aguado, Hector J., McGillion, Michael, Lamy, Andre, Whitlock, Richard P., Roshanov, Pavel, Stillo, David, Copland, Ingrid, Vincent, Jessica, Balasubramanian, Kumar, Bangdiwala, Shrikant I., Biccard, Bruce, Kurz, Andrea, Srinathan, Sadeesh, Petit, Shirley, Eikelboom, John, Richards, Toby, Gross, Peter L., Alfonsi, Pascal, Guyatt, Gordon, Belley-Cote, Emily, Spence, Jessica, McIntyre, William, Yusuf, Salim, and Devereaux, P. J.
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ComputingMilieux_THECOMPUTINGPROFESSION ,Data_FILES ,GeneralLiterature_REFERENCE(e.g.,dictionaries,encyclopedias,glossaries) - Abstract
Additional file 10. List of investigators and committees.
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- 2022
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5. Additional file 8 of Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3): a randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery
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Marcucci, Maura, Painter, Thomas W., Conen, David, Leslie, Kate, Lomivorotov, Vladimir V., Sessler, Daniel, Chan, Matthew T. V., Borges, Flavia K., Mart��nez Zapata, Maria J., Wang, C. Y., Xavier, Denis, Ofori, Sandra N., Landoni, Giovanni, Efremov, Sergey, Kleinlugtenbelt, Ydo V., Szczeklik, Wojciech, Schmartz, Denis, Garg, Amit X., Short, Timothy G., Wittmann, Maria, Meyhoff, Christian S., Amir, Mohammed, Torres, David, Patel, Ameen, Duceppe, Emmanuelle, Ruetzler, Kurtz, Parlow, Joel L., Tandon, Vikas, Wang, Michael K., Fleischmann, Edith, Polanczyk, Carisi A., Jayaram, Raja, Astrakov, Sergey V., Rao, Mangala, VanHelder, Tomas, Wu, William K. K., Cheong, Chao Chia, Ayad, Sabry, Abubakirov, Marat, Kirov, Mikhail, Bhatt, Keyur, de Nadal, Miriam, Likhvantsev, Valery, Iglesisas, Pilar Paniagua, Aguado, Hector J., McGillion, Michael, Lamy, Andre, Whitlock, Richard P., Roshanov, Pavel, Stillo, David, Copland, Ingrid, Vincent, Jessica, Balasubramanian, Kumar, Bangdiwala, Shrikant I., Biccard, Bruce, Kurz, Andrea, Srinathan, Sadeesh, Petit, Shirley, Eikelboom, John, Richards, Toby, Gross, Peter L., Alfonsi, Pascal, Guyatt, Gordon, Belley-Cote, Emily, Spence, Jessica, McIntyre, William, Yusuf, Salim, and Devereaux, P. J.
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Additional file 8. POISE-3 organizational structure and oversight of trial conduct.
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- 2022
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6. Additional file 5 of Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3): a randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery
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Marcucci, Maura, Painter, Thomas W., Conen, David, Leslie, Kate, Lomivorotov, Vladimir V., Sessler, Daniel, Chan, Matthew T. V., Borges, Flavia K., Mart��nez Zapata, Maria J., Wang, C. Y., Xavier, Denis, Ofori, Sandra N., Landoni, Giovanni, Efremov, Sergey, Kleinlugtenbelt, Ydo V., Szczeklik, Wojciech, Schmartz, Denis, Garg, Amit X., Short, Timothy G., Wittmann, Maria, Meyhoff, Christian S., Amir, Mohammed, Torres, David, Patel, Ameen, Duceppe, Emmanuelle, Ruetzler, Kurtz, Parlow, Joel L., Tandon, Vikas, Wang, Michael K., Fleischmann, Edith, Polanczyk, Carisi A., Jayaram, Raja, Astrakov, Sergey V., Rao, Mangala, VanHelder, Tomas, Wu, William K. K., Cheong, Chao Chia, Ayad, Sabry, Abubakirov, Marat, Kirov, Mikhail, Bhatt, Keyur, de Nadal, Miriam, Likhvantsev, Valery, Iglesisas, Pilar Paniagua, Aguado, Hector J., McGillion, Michael, Lamy, Andre, Whitlock, Richard P., Roshanov, Pavel, Stillo, David, Copland, Ingrid, Vincent, Jessica, Balasubramanian, Kumar, Bangdiwala, Shrikant I., Biccard, Bruce, Kurz, Andrea, Srinathan, Sadeesh, Petit, Shirley, Eikelboom, John, Richards, Toby, Gross, Peter L., Alfonsi, Pascal, Guyatt, Gordon, Belley-Cote, Emily, Spence, Jessica, McIntyre, William, Yusuf, Salim, and Devereaux, P. J.
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Additional file 5. POISE-3 tertiary outcomes.
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- 2022
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7. sj-docx-1-cjk-10.1177_20543581211069225 ��� Supplemental material for Effect of a Perioperative Hypotension-Avoidance Strategy Versus a Hypertension-Avoidance Strategy on the Risk of Acute Kidney Injury: A Clinical Research Protocol for a Substudy of the POISE-3 Randomized Clinical Trial
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Garg, Amit X., Cuerden, Meaghan, Aguado, Hector, Amir, Mohammed, Belley-Cote, Emilie P., Bhatt, Keyur, Biccard, Bruce M., Borges, Flavia K., Chan, Matthew, Conen, David, Duceppe, Emmanuelle, Efremov, Sergey, Eikelboom, John, Fleischmann, Edith, Giovanni, Landoni, Gross, Peter, Jayaram, Raja, Kirov, Mikhail, Kleinlugtenbelt, Ydo, Kurz, Andrea, Lamy, Andre, Leslie, Kate, Likhvantsev, Valery, Lomivorotov, Vladimir, Marcucci, Maura, Mart��nez-Zapata, Maria Jos��, McGillion, Michael, McIntyre, William, Meyhoff, Christian, Ofori, Sandra, Painter, Thomas, Paniagua, Pilar, Parikh, Chirag, Parlow, Joel, Patel, Ameen, Polanczyk, Carisi, Richards, Toby, Roshanov, Pavel, Schmartz, Denis, Sessler, Daniel, Short, Tim, Sontrop, Jessica M., Spence, Jessica, Srinathan, Sadeesh, Stillo, David, Szczeklik, Wojciech, Tandon, Vikas, Torres, David, Van Helder, Thomas, Vincent, Jessica, Wang, C. Y., Wang, Michael, Whitlock, Richard, Wittmann, Maria, Xavier, Denis, and Devereaux, P. J.
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Medicine - Abstract
Supplemental material, sj-docx-1-cjk-10.1177_20543581211069225 for Effect of a Perioperative Hypotension-Avoidance Strategy Versus a Hypertension-Avoidance Strategy on the Risk of Acute Kidney Injury: A Clinical Research Protocol for a Substudy of the POISE-3 Randomized Clinical Trial by Amit X. Garg, Meaghan Cuerden, Hector Aguado, Mohammed Amir, Emilie P. Belley-Cote, Keyur Bhatt, Bruce M. Biccard, Flavia K. Borges, Matthew Chan, David Conen, Emmanuelle Duceppe, Sergey Efremov, John Eikelboom, Edith Fleischmann, Landoni Giovanni, Peter Gross, Raja Jayaram, Mikhail Kirov, Ydo Kleinlugtenbelt, Andrea Kurz, Andre Lamy, Kate Leslie, Valery Likhvantsev, Vladimir Lomivorotov, Maura Marcucci, Maria Jos�� Mart��nez-Zapata, Michael McGillion, William McIntyre, Christian Meyhoff, Sandra Ofori, Thomas Painter, Pilar Paniagua, Chirag Parikh, Joel Parlow, Ameen Patel, Carisi Polanczyk, Toby Richards, Pavel Roshanov, Denis Schmartz, Daniel Sessler, Tim Short, Jessica M. Sontrop, Jessica Spence, Sadeesh Srinathan, David Stillo, Wojciech Szczeklik, Vikas Tandon, David Torres, Thomas Van Helder, Jessica Vincent, C. Y. Wang, Michael Wang, Richard Whitlock, Maria Wittmann, Denis Xavier and P. J. Devereaux in Canadian Journal of Kidney Health and Disease
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- 2022
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8. Additional file 1 of Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3): a randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery
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Marcucci, Maura, Painter, Thomas W., Conen, David, Leslie, Kate, Lomivorotov, Vladimir V., Sessler, Daniel, Chan, Matthew T. V., Borges, Flavia K., Mart��nez Zapata, Maria J., Wang, C. Y., Xavier, Denis, Ofori, Sandra N., Landoni, Giovanni, Efremov, Sergey, Kleinlugtenbelt, Ydo V., Szczeklik, Wojciech, Schmartz, Denis, Garg, Amit X., Short, Timothy G., Wittmann, Maria, Meyhoff, Christian S., Amir, Mohammed, Torres, David, Patel, Ameen, Duceppe, Emmanuelle, Ruetzler, Kurtz, Parlow, Joel L., Tandon, Vikas, Wang, Michael K., Fleischmann, Edith, Polanczyk, Carisi A., Jayaram, Raja, Astrakov, Sergey V., Rao, Mangala, VanHelder, Tomas, Wu, William K. K., Cheong, Chao Chia, Ayad, Sabry, Abubakirov, Marat, Kirov, Mikhail, Bhatt, Keyur, de Nadal, Miriam, Likhvantsev, Valery, Iglesisas, Pilar Paniagua, Aguado, Hector J., McGillion, Michael, Lamy, Andre, Whitlock, Richard P., Roshanov, Pavel, Stillo, David, Copland, Ingrid, Vincent, Jessica, Balasubramanian, Kumar, Bangdiwala, Shrikant I., Biccard, Bruce, Kurz, Andrea, Srinathan, Sadeesh, Petit, Shirley, Eikelboom, John, Richards, Toby, Gross, Peter L., Alfonsi, Pascal, Guyatt, Gordon, Belley-Cote, Emily, Spence, Jessica, McIntyre, William, Yusuf, Salim, and Devereaux, P. J.
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Additional file 1. POISE-3 SPIRIT checklist.
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- 2022
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9. Additional file 3 of Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3): a randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery
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Marcucci, Maura, Painter, Thomas W., Conen, David, Leslie, Kate, Lomivorotov, Vladimir V., Sessler, Daniel, Chan, Matthew T. V., Borges, Flavia K., Mart��nez Zapata, Maria J., Wang, C. Y., Xavier, Denis, Ofori, Sandra N., Landoni, Giovanni, Efremov, Sergey, Kleinlugtenbelt, Ydo V., Szczeklik, Wojciech, Schmartz, Denis, Garg, Amit X., Short, Timothy G., Wittmann, Maria, Meyhoff, Christian S., Amir, Mohammed, Torres, David, Patel, Ameen, Duceppe, Emmanuelle, Ruetzler, Kurtz, Parlow, Joel L., Tandon, Vikas, Wang, Michael K., Fleischmann, Edith, Polanczyk, Carisi A., Jayaram, Raja, Astrakov, Sergey V., Rao, Mangala, VanHelder, Tomas, Wu, William K. K., Cheong, Chao Chia, Ayad, Sabry, Abubakirov, Marat, Kirov, Mikhail, Bhatt, Keyur, de Nadal, Miriam, Likhvantsev, Valery, Iglesisas, Pilar Paniagua, Aguado, Hector J., McGillion, Michael, Lamy, Andre, Whitlock, Richard P., Roshanov, Pavel, Stillo, David, Copland, Ingrid, Vincent, Jessica, Balasubramanian, Kumar, Bangdiwala, Shrikant I., Biccard, Bruce, Kurz, Andrea, Srinathan, Sadeesh, Petit, Shirley, Eikelboom, John, Richards, Toby, Gross, Peter L., Alfonsi, Pascal, Guyatt, Gordon, Belley-Cote, Emily, Spence, Jessica, McIntyre, William, Yusuf, Salim, and Devereaux, P. J.
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Additional file 3. Rationale for POISE-3 study dosing regimen of tranexamic acid.
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- 2022
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10. Additional file 6 of Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3): a randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery
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Marcucci, Maura, Painter, Thomas W., Conen, David, Leslie, Kate, Lomivorotov, Vladimir V., Sessler, Daniel, Chan, Matthew T. V., Borges, Flavia K., Mart��nez Zapata, Maria J., Wang, C. Y., Xavier, Denis, Ofori, Sandra N., Landoni, Giovanni, Efremov, Sergey, Kleinlugtenbelt, Ydo V., Szczeklik, Wojciech, Schmartz, Denis, Garg, Amit X., Short, Timothy G., Wittmann, Maria, Meyhoff, Christian S., Amir, Mohammed, Torres, David, Patel, Ameen, Duceppe, Emmanuelle, Ruetzler, Kurtz, Parlow, Joel L., Tandon, Vikas, Wang, Michael K., Fleischmann, Edith, Polanczyk, Carisi A., Jayaram, Raja, Astrakov, Sergey V., Rao, Mangala, VanHelder, Tomas, Wu, William K. K., Cheong, Chao Chia, Ayad, Sabry, Abubakirov, Marat, Kirov, Mikhail, Bhatt, Keyur, de Nadal, Miriam, Likhvantsev, Valery, Iglesisas, Pilar Paniagua, Aguado, Hector J., McGillion, Michael, Lamy, Andre, Whitlock, Richard P., Roshanov, Pavel, Stillo, David, Copland, Ingrid, Vincent, Jessica, Balasubramanian, Kumar, Bangdiwala, Shrikant I., Biccard, Bruce, Kurz, Andrea, Srinathan, Sadeesh, Petit, Shirley, Eikelboom, John, Richards, Toby, Gross, Peter L., Alfonsi, Pascal, Guyatt, Gordon, Belley-Cote, Emily, Spence, Jessica, McIntyre, William, Yusuf, Salim, and Devereaux, P. J.
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Additional file 6. POISE-3 outcome definitions.
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- 2022
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11. Assisted Fluid Management Software Guidance for Intraoperative Fluid Administration
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Maheshwari, Kamal, Malhotra, Gaurav, Bao, Xiaodong, Lahsaei, Peiman, Hand, William R, Fleming, Neal W, Ramsingh, Davinder, Treggiari, Miriam M, Sessler, Daniel I, Miller, Timothy E, and Assisted Fluid Management Study Team
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Male ,Intraoperative Care ,Assisted Fluid Management Study Team ,Clinical Sciences ,Bioengineering ,Middle Aged ,Cohort Studies ,Computer-Assisted ,Clinical Research ,Anesthesiology ,Humans ,Fluid Therapy ,Female ,Therapy ,Aged - Abstract
BackgroundExcessive or inadequate fluid administration causes complications, but despite this, fluid administration during noncardiac surgery is highly variable. Goal-directed management helps optimize the amount and timing of fluid administration; however, implementation is difficult because algorithms are complex. The authors therefore tested the performance of the Acumen Assisted Fluid Management software (Edwards Lifesciences, USA), which is designed to guide optimal intravenous fluid administration during surgery.MethodsIn this multicenter, prospective, single-arm cohort evaluation, the authors enrolled 330 adults scheduled for moderate- to high-risk noncardiac surgery that required arterial catheter insertion and mechanical ventilation. Clinicians chose a fluid strategy based on a desired 10%, 15%, or 20% increase in stroke volume (SV) in response to a fluid bolus. Dedicated fluid management software prompted "test" or "recommended" boluses, and clinicians were free to initiate a "user" bolus of 100 to 500 ml of crystalloid or colloid. Clinicians were free to accept or decline the software prompts. The authors primarily compared the fraction of software-recommended boluses that produced suitable increases in SV to a 30% reference rate. On an exploratory basis, we compared responses to software-recommended and clinician-initiated boluses.ResultsFour hundred twenty-four of 479 (89%) software-recommended fluid boluses and 508 of 592 (86%) clinician-initiated fluid boluses were analyzed per protocol. Of those, 66% (95% CI, 62 to 70%) of delivered fluid boluses recommended by the software resulted in desired increases in SV, compared with the 30% reference rate, whereas only 41% (95% CI, 38 to 44%) of clinician-initiated boluses did (P < 0.0001). The mean ± SD increase in SV after boluses recommended by the software was 14.2 ± 13.9% versus 8.3 ± 12.1% (P < 0.0001) for those initiated by clinicians.ConclusionsFluid boluses recommended by the software resulted in desired SV increases more often, and with greater absolute SV increase, than clinician-initiated boluses. Automated assessment of fluid responsiveness may help clinicians optimize intraoperative fluid management during noncardiac surgery.Editor’s perspective
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- 2021
12. Ambulatory continuous peripheral nerve blocks to treat postamputation phantom limb pain: a multicenter, randomized, quadruple-masked, placebo-controlled clinical trial
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Ilfeld, Brian M, Khatibi, Bahareh, Maheshwari, Kamal, Madison, Sarah J, Esa, Wael Ali Sakr, Mariano, Edward R, Kent, Michael L, Hanling, Steven, Sessler, Daniel I, Eisenach, James C, Cohen, Steven P, Mascha, Edward J, Ma, Chao, Padwal, Jennifer A, Turan, Alparslan, and PAINfRE Investigators
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Pain Research ,Psychology and Cognitive Sciences ,Clinical Trials and Supportive Activities ,Neurosciences ,Evaluation of treatments and therapeutic interventions ,Pain ,Nerve Block ,Continuous peripheral nerve blocks ,Chronic pain ,Perineural local anesthetic infusion ,Medical and Health Sciences ,Phantom Limb ,Local ,Clinical Research ,Anesthesiology ,6.1 Pharmaceuticals ,PAINfRE Investigators ,Neurological ,Humans ,Ropivacaine ,Peripheral Nerves ,Postoperative ,Peripheral Neuropathy ,Ambulatory analgesia ,Anesthetics - Abstract
Phantom limb pain is thought to be sustained by reentrant neural pathways, which provoke dysfunctional reorganization in the somatosensory cortex. We hypothesized that disrupting reentrant pathways with a 6-day-long continuous peripheral nerve block reduces phantom pain 4 weeks after treatment. We enrolled patients who had an upper- or lower-limb amputation and established phantom pain. Each was randomized to receive a 6-day perineural infusion of either ropivacaine or normal saline. The primary outcome was the average phantom pain severity as measured with a Numeric Rating Scale (0-10) at 4 weeks, after which an optional crossover treatment was offered within the following 0 to 12 weeks. Pretreatment pain scores were similar in both groups, with a median (interquartile range) of 5.0 (4.0, 7.0) for each. After 4 weeks, average phantom limb pain intensity was a mean (SD) of 3.0 (2.9) in patients given local anesthetic vs 4.5 (2.6) in those given placebo (difference [95% confidence interval] 1.3 [0.4, 2.2], P = 0.003). Patients given local anesthetic had improved global impression of change and less pain-induced physical and emotional dysfunction, but did not differ on depression scores. For subjects who received only the first infusion (no self-selected crossover), the median decrease in phantom limb pain at 6 months for treated subjects was 3.0 (0, 5.0) vs 1.5 (0, 5.0) for the placebo group; there seemed to be little residual benefit at 12 months. We conclude that a 6-day continuous peripheral nerve block reduces phantom limb pain as well as physical and emotional dysfunction for at least 1 month.
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- 2021
13. Association Between Postoperative Haemoglobin And Myocardial Injury After Noncardiac Surgery: A Retrospective Cohort Analysis
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Turan, Alparslan, Cohen, Barak, Rivas, Eva, Liu, Liu, Pu, Xuan, Maheshwari, Kamal, Farag, Ehab, Onal, Ozkan, Wang, Jiayi, Ruetzler, Kurt, Devereaux, Philip J., and Sessler, Daniel, I
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Background: Myocardial injury after noncardiac surgery (MINS) is common, mostly silent, and a strong predictor of postoperative mortality. MINS appears to result from myocardial supply-demand mismatch. Recent data support restrictive perioperative transfusion strategies that can result in low postoperative haemoglobin concentrations. Whether low postoperative haemoglobin is associated with myocardial injury remains unknown. We therefore tested the hypothesis that anaemia is associated with an increased risk of myocardial injury in adults having noncardiac surgery.
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- 2021
14. Additional file of ABO blood types and sepsis mortality
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Itenov, Theis S., Sessler, Daniel I., Khanna, Ashish K., Ostrowski, Sisse R., Johansson, Pär I., Erikstrup, Christian, Pedersen, Ole B., Rygård, Sofie L., Holst, Lars B., Bestle, Morten H., Hein, Lars, Lindhardt, Anne, Tousi, Hami, Andersen, Mads H., Mohr, Thomas, Lundgren, Jens D., and Jens-Ulrik Jensen
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congenital, hereditary, and neonatal diseases and abnormalities ,hemic and lymphatic diseases ,parasitic diseases ,biological factors - Abstract
Additional file of ABO blood types and sepsis mortality
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- 2021
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15. Additional file 3 of Impact of dexmedetomidine supplemented analgesia on delirium in patients recovering from orthopedic surgery: A randomized controlled trial
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Hong, Hong, Zhang, Da-Zhi, Li, Mo, Wang, Geng, Zhu, Sai-Nan, Zhang, Yue, Wang, Dong-Xin, and Sessler, Daniel I.
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Additional file 3: Supplemental Table S1. Pain, sedation, and subjective sleep quality within 5 days after surgery.
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- 2021
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16. Additional file 1 of Impact of dexmedetomidine supplemented analgesia on delirium in patients recovering from orthopedic surgery: A randomized controlled trial
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Hong, Hong, Zhang, Da-Zhi, Li, Mo, Wang, Geng, Zhu, Sai-Nan, Zhang, Yue, Wang, Dong-Xin, and Sessler, Daniel I.
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Additional file 1: Supplemental Figure S1. Daily prevalence of postoperative delirium. Sample sizes differ from the first to fifth day because some patients were discharged from hospital during this period.
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- 2021
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17. Additional file 2 of ABO blood types and sepsis mortality
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Itenov, Theis S., Sessler, Daniel I., Khanna, Ashish K., Ostrowski, Sisse R., Johansson, Pär I., Erikstrup, Christian, Pedersen, Ole B., Rygård, Sofie L., Holst, Lars B., Bestle, Morten H., Hein, Lars, Lindhardt, Anne, Tousi, Hami, Andersen, Mads H., Mohr, Thomas, Lundgren, Jens D., and Jens-Ulrik Jensen
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parasitic diseases ,bacterial infections and mycoses ,hormones, hormone substitutes, and hormone antagonists - Abstract
Additional file 2. Level of endothelial damage markers across the blood types in the Procalcitonin and Survival Study (PASS) cohort.
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- 2021
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18. Additional file 4 of Impact of dexmedetomidine supplemented analgesia on delirium in patients recovering from orthopedic surgery: A randomized controlled trial
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Hong, Hong, Zhang, Da-Zhi, Li, Mo, Wang, Geng, Zhu, Sai-Nan, Zhang, Yue, Wang, Dong-Xin, and Sessler, Daniel I.
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Additional file 4: Supplemental Table S2. Individual complications after surgery
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- 2021
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19. Additional file 1 of ABO blood types and sepsis mortality
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Itenov, Theis S., Sessler, Daniel I., Khanna, Ashish K., Ostrowski, Sisse R., Johansson, Pär I., Erikstrup, Christian, Pedersen, Ole B., Rygård, Sofie L., Holst, Lars B., Bestle, Morten H., Hein, Lars, Lindhardt, Anne, Tousi, Hami, Andersen, Mads H., Mohr, Thomas, Lundgren, Jens D., and Jens-Ulrik Jensen
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urogenital system ,health care facilities, manpower, and services ,urologic and male genital diseases ,female genital diseases and pregnancy complications - Abstract
Additional file 1. Risk of AKI within 4 days of ICU admission.
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- 2021
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20. Additional file 2 of Impact of dexmedetomidine supplemented analgesia on delirium in patients recovering from orthopedic surgery: A randomized controlled trial
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Hong, Hong, Zhang, Da-Zhi, Li, Mo, Wang, Geng, Zhu, Sai-Nan, Zhang, Yue, Wang, Dong-Xin, and Sessler, Daniel I.
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Additional file 2: Supplemental Figure S2. Forest plot assessing the effect of dexmedetomidine supplemented analgesia versus placebo in predefined subgroups. The interactions between treatment effect and predefined factors were assessed separately with logistic regression models. MMSE, Mini-Mental Status Examination.
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- 2021
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21. Additional file 5 of Tranexamic acid and rosuvastatin in patients at risk of cardiovascular events after noncardiac surgery: a pilot of the POISE-3 randomized controlled trial
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Marcucci, Maura, Duceppe, Emmanuelle, Manach, Yannick Le, Kearon, Clive, Eikelboom, John W., Pohl, Kayla, Vincent, Jessica, Darvish-Kazem, Saeed, Sadeesh K. Srinathan, Neary, John D. D., Parlow, Joel L., Kurz, Andrea, Gross, Peter L., Mrkobrada, Marko, Balasubramanian, Kumar, Sessler, Daniel I., and P. J. Devereaux
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sense organs ,skin and connective tissue diseases - Abstract
Additional File 5. Additional Table. Effect of TXA on hemoglobin change from preoperative to post-operative day 1, and from preoperative to the lowest postoperative level.
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- 2020
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22. Additional file 2 of Tranexamic acid and rosuvastatin in patients at risk of cardiovascular events after noncardiac surgery: a pilot of the POISE-3 randomized controlled trial
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Marcucci, Maura, Duceppe, Emmanuelle, Manach, Yannick Le, Kearon, Clive, Eikelboom, John W., Pohl, Kayla, Vincent, Jessica, Darvish-Kazem, Saeed, Sadeesh K. Srinathan, Neary, John D. D., Parlow, Joel L., Kurz, Andrea, Gross, Peter L., Mrkobrada, Marko, Balasubramanian, Kumar, Sessler, Daniel I., and P. J. Devereaux
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nutritional and metabolic diseases - Abstract
Additional File 2. Definitions of postoperative drug discontinuation in the rosuvastatin trial.
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- 2020
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23. Additional file 4 of Tranexamic acid and rosuvastatin in patients at risk of cardiovascular events after noncardiac surgery: a pilot of the POISE-3 randomized controlled trial
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Marcucci, Maura, Duceppe, Emmanuelle, Manach, Yannick Le, Kearon, Clive, Eikelboom, John W., Pohl, Kayla, Vincent, Jessica, Darvish-Kazem, Saeed, Sadeesh K. Srinathan, Neary, John D. D., Parlow, Joel L., Kurz, Andrea, Gross, Peter L., Mrkobrada, Marko, Balasubramanian, Kumar, Sessler, Daniel I., and P. J. Devereaux
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Additional File 4. Additional table. Patient characteristics at baseline: medications.
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- 2020
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24. Additional file 1 of Tranexamic acid and rosuvastatin in patients at risk of cardiovascular events after noncardiac surgery: a pilot of the POISE-3 randomized controlled trial
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Marcucci, Maura, Duceppe, Emmanuelle, Manach, Yannick Le, Kearon, Clive, Eikelboom, John W., Pohl, Kayla, Vincent, Jessica, Darvish-Kazem, Saeed, Sadeesh K. Srinathan, Neary, John D. D., Parlow, Joel L., Kurz, Andrea, Gross, Peter L., Mrkobrada, Marko, Balasubramanian, Kumar, Sessler, Daniel I., and P. J. Devereaux
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Additional File 1. CONSORT checklist for POISE-3 Pilot manuscript
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- 2020
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25. Additional file 3 of Tranexamic acid and rosuvastatin in patients at risk of cardiovascular events after noncardiac surgery: a pilot of the POISE-3 randomized controlled trial
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Marcucci, Maura, Duceppe, Emmanuelle, Manach, Yannick Le, Kearon, Clive, Eikelboom, John W., Pohl, Kayla, Vincent, Jessica, Darvish-Kazem, Saeed, Sadeesh K. Srinathan, Neary, John D. D., Parlow, Joel L., Kurz, Andrea, Gross, Peter L., Mrkobrada, Marko, Balasubramanian, Kumar, Sessler, Daniel I., and P. J. Devereaux
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nutritional and metabolic diseases - Abstract
Additional File 3. List of prespecfied clinical outcomes for the tranexamic acid versus placebo and the rosuvastatin versus placebo trials.
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- 2020
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26. Effect of methylprednisolone on acute kidney injury in patients undergoing cardiac surgery with a cardiopulmonary bypass pump: a randomized controlled trial
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Garg, Amit X, Chan, Matthew TV, Cuerden, Meaghan S, Devereaux, PJ, Abbasi, Seyed Hesameddin, Hildebrand, Ainslie, Lamontagne, Francois, Lamy, Andre, Noiseux, Nicolas, Parikh, Chirag R, Perkovic, Vlado, Quantz, Mackenzie, Rochon, Antoine, Royse, Alistair, Sessler, Daniel I, Shah, Pallav J, Sontrop, Jessica M, Tagarakis, Georgios I, Teoh, Kevin H, Vincent, Jessica, Walsh, Michael, Yared, Jean-Pierre, Yusuf, Salim, Whitlock, Richard P, Whitlock, R, Semelhago, L, Chu, V, Dyub, A, Cybulsky, I, Van Oosteen, R, Cordova, G, Quantz, MA, McKenzie, FN, Fox, S, Chase, L, Stevens, LM, Prieto, I, Basile, F, Finegan, BA, Bryden, C, Meyer, S, Chappell, A, Mazer, CD, Dixon, J, Yagnik, S, Crescini, C, Verma, S, Legare, JF, Greentree, D, Coutu, M, Teijeira, J, Wiley, W, Peniston, C, Teng, C, Rochon, AG, Lamarche, Y, Deschamps, A, Voisine, P, Dagenais, F, Singal, RK, Brown, CD, Kieser, TM, Robinson, R, Fremes, SE, Christakis, GT, Melvin, KN, Parsons, M, Zheng, H, Yu, J, Xu, W, Zhang, Q, Chen, C, Yu, H, Zeng, J, Zuo, Y, Liu, J, Zhang, T, Sun, Y, Song, D, Dong, H, Chen, M, Zhao, J, Tao, L, Huang, W, Cheng, Y, Long, YS, Lei, W, Zhang, W, Xu, MY, Qing, E, Xiao, YB, Karunakaran, J, Pillai, VV, Reddy, PB, Kundan, S, Jain, AR, Mallya, SS, Mehta, CB, Shukla, V, Kuruvila, K, Karthikeyan, G, Devagourou, V, Hote, MP, Airan, B, Padmanabhan, C, Srinivasan, M, Agarwal, SK, Pande, S, Rao, P Simha Mohan, Math, R, Shankar, BPR, Vaijyanath, PH, Nair, SK, Ayapati, DR, Kurz, A, Awais, A, Panjasawatwong, K, Kashy, BK, Huffmyer, JL, Scalzo, DC, Kazemi, A, Huang, KF, Parvathaneni, SV, Gardner, JC, Malik, MR, Eshraghi, Y, Kramer, RS, Essandoh, MK, Portillo, J, Ayad, SS, Akhtar, Z, Castresana, MR, Collard, CD, Rodriguez-Blanco, YF, Eaton, MP, Villar, JC, Umana, JP, Dominguez, CL, Alvarado, PA, Zuluaga, D, Abello, M, Sarquis, T, Vaquiro, E, Oliveros, CA, Manrique, EJ, Vasquez, S, Ortiz, LM, Holliday, J, Griffin, R, Royse, AG, Royse, CF, Williams, Z, Paparella, D, Rotunno, C, De Palo, M, Margari, V, Alfieri, O, Ferrara, D, Schiavi, D, Parolari, A, Myasoedova, VA, Daprati, A, De Feo, M, Bancone, C, Di Bartolomeo, R, Pacini, D, Ribezzo, M, Karimi, A, Salehiomran, A, Hajighasemi, A, Bina, P, Straka, Z, Hlavicka, J, Lukac, P, Vik, K, Mosna, F, Tsilimingas, NB, Simopoulos, VN, Tsolaki, F, Rivilla, MT, Galan, J, Nunez, JAF, Gonzalez, A, Ruiz, D, Orts Rodriguez, M, Issa, M, Vila Nova, DC, Maia, LN, Nakazone, MA, Lico e Cividanes, GV, Hajjar, LA, Neto, V Avila, Lucchese, FA, Stolf, NA, Hutschala, D, Ruetzler, K, Sima, B, Engelen, S, Borms, S, Van De Velde, M, Rex, S, De Hert, SG, Ho, AMH, Chan, MTV, Underwood, MJ, Deluca Bisurgi, D, Torres, D, and Buggy, DJ
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Male ,medicine.medical_specialty ,medicine.medical_treatment ,Anti-Inflammatory Agents ,030204 cardiovascular system & hematology ,Methylprednisolone ,Drug Administration Schedule ,law.invention ,03 medical and health sciences ,Medicine, General & Internal ,0302 clinical medicine ,Postoperative Complications ,Randomized controlled trial ,law ,General & Internal Medicine ,Cardiopulmonary bypass ,SIRS ,Medicine ,Humans ,030212 general & internal medicine ,Cardiac Surgical Procedures ,Glucocorticoids ,Dialysis ,Aged ,Science & Technology ,Cardiopulmonary Bypass ,business.industry ,STEROIDS ,Research ,Acute kidney injury ,General Medicine ,Perioperative ,Acute Kidney Injury ,Middle Aged ,medicine.disease ,Cardiac surgery ,HIGH-DOSE DEXAMETHASONE ,Anesthesia ,Female ,business ,Life Sciences & Biomedicine ,Kidney disease ,medicine.drug - Abstract
BACKGROUND: Perioperative corticosteroid use may reduce acute kidney injury. We sought to test whether methylprednisolone reduces the risk of acute kidney injury after cardiac surgery. METHODS: We conducted a prespecified substudy of a randomized controlled trial involving patients undergoing cardiac surgery with cardiopulmonary bypass (2007-2014); patients were recruited from 79 centres in 18 countries. Eligibility criteria included a moderate-to-high risk of perioperative death based on a preoperative score of 6 or greater on the European System for Cardiac Operative Risk Evaluation I. Patients (n = 7286) were randomly assigned (1:1) to receive intravenous methylprednisolone (250 mg at anesthetic induction and 250 mg at initiation of cardiopulmonary bypass) or placebo. Patients, caregivers, data collectors and outcome adjudicators were unaware of the assigned intervention. The primary outcome was postoperative acute kidney injury, defined as an increase in the serum creatinine concentration (from the preoperative value) of 0.3 mg/dL or greater (≥ 26.5 μmol/L) or 50% or greater in the 14-day period after surgery, or use of dialysis within 30 days after surgery. RESULTS: Acute kidney injury occurred in 1479/3647 patients (40.6%) in the methylprednisolone group and in 1426/3639 patients (39.2%) in the placebo group (adjusted relative risk 1.04, 95% confidence interval 0.96 to 1.11). Results were consistent across several definitions of acute kidney injury and in patients with preoperative chronic kidney disease. INTERPRETATION: Intraoperative corticosteroid use did not reduce the risk of acute kidney injury in patients with a moderate-to-high risk of perioperative death who had cardiac surgery with cardiopulmonary bypass. Our results do not support the prophylactic use of steroids during cardiopulmonary bypass surgery. Trial registration: ClinicalTrials.gov, no. NCT00427388. ispartof: CANADIAN MEDICAL ASSOCIATION JOURNAL vol:191 issue:9 pages:E247-E256 ispartof: location:Canada status: published
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- 2019
27. Additional file 1: of Hypotension Prediction Index software for management of hypotension during moderate- to high-risk noncardiac surgery: protocol for a randomized trial
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Maheshwari, Kamal, Shimada, Tetsuya, Fang, Jonathan, Ilker Ince, Mascha, Edward, Turan, Alparslan, Kurz, Andrea, and Sessler, Daniel
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SPIRIT 2013 checklist: Recommended items to address in a clinical trial protocol and related documents. (DOC 130 kb)
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- 2019
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28. Acetaminophen Reduces Acute And Persistent Incisional Pain After Hysterectomy
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Koyuncu, Onur, Hakimoglu, Sedat, Ugur, Mustafa, Akkurt, Cagla, Turhanoglu, Selim, Sessler, Daniel, and Turan, Alparslan
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stomatognathic diseases ,organic chemicals ,digestive, oral, and skin physiology ,digestive system ,digestive system diseases - Abstract
OBJECTIVE: Acetaminophen is effective for acute surgical pain, but whether it reduces persistent incision pain remains unknown. We tested the primary hypothesis that patients given perioperative acetaminophen have less incisional pain three months after surgery. Our secondary hypotheses were that patients randomized to acetaminophen have less postoperative pain and analgesic consumption, and better functional recovery at three months.
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- 2018
29. Blind intubation through self-pressurized, disposable supraglottic airway laryngeal intubation masks: an international, multicenter, prospective cohort study
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Ruetzler, Kurt, Guzzella, Sandra Esther, Tscholl, David Werner, Restin, Tanja, Cribari, Marco, Turan, Alparslan, You, Jing, Sessler, Daniel I, Seifert, Burkhardt, Gaszynski, Tomasz, Ganter, Michael T, Spahn, Donat R, University of Zurich, and Ruetzler, Kurt
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Anesthesiology and Pain Medicine ,10216 Institute of Anesthesiology ,610 Medicine & health ,10060 Epidemiology, Biostatistics and Prevention Institute (EBPI) ,2703 Anesthesiology and Pain Medicine - Published
- 2017
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30. Physician patients Having Non-cardiac Surgery: a Registry Analysis of VIP Syndrome
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Azfar Niazi, Krit Panjasawatwong, Peirong Lin, Karimi, Nika, Ms, Jing You, and Sessler, Daniel
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- 2016
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31. Association of Postoperative High-Sensitivity Troponin Levels With Myocardial Injury and 30-Day Mortality Among Patients Undergoing Noncardiac Surgery
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Devereaux, P.J., Biccard, Bruce M., Sigamani, Alben, Xavier, Denis, Chan, Matthew T. V., Srinathan, Sadeesh K., Walsh, Michael, Abraham, Valsa, Pearse, Rupert, Wang, Y., Sessler, Daniel I., Kurz, Andrea, Szczeklik, Wojciech, Berwanger, Otavio, Villar, Juan Carlos, Malaga, German, Garg, Amit X., Chow, Clara K., Ackland, Gareth, Patel, Ameen, Kessler Borges, Flavia, Belley-Cote, Emilie P., Duceppe, Emmanuelle, Spence, Jessica, Tandon, Vikas, Williams, Colin, Sapsford, Robert J., Polanczyk, Carisi A., Tiboni, Maria, Alonso-Coello, Pablo, Faruqui, Atiya, Heels-Ansdell, Diane, Lamy, Andre, Whitlock, Richard, LeManach, Yannick, Roshanov, Pavel S., McGillion, Michael, Kavsak, Peter, McQueen, Matthew J., Thabane, Lehana, Rodseth, Reitze N., Lurati Buse, Giovanna A., Bhandari, Mohit, Garutti, Ignacia, Jacka, Michael J., Schunemann, Holger J., Cortes, Olga Lucia, Coriat, Pierre, Dvirnik, Nazari, Botto, Fernando, Pettit, Shirley, Jaffe, Allan S., Guyatt, Gordon H., and VISION Study Investigators
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Male ,Myocardial Ischemia/mortality ,Myocardial Infarction ,Myocardial Ischemia ,030204 cardiovascular system & hematology ,Risk Assessment ,Preoperative care ,03 medical and health sciences ,Postoperative Complications ,0302 clinical medicine ,Troponin T ,030202 anesthesiology ,medicine ,Humans ,Prospective Studies ,Postoperative Period ,Myocardial infarction ,Prospective cohort study ,Myocardial Infarction/mortality ,Aged ,Troponin T/blood ,medicine.diagnostic_test ,business.industry ,Hazard ratio ,General Medicine ,Perioperative ,Middle Aged ,medicine.disease ,purl.org/pe-repo/ocde/ford#3.02.00 [https] ,Editorial ,Anesthesia ,Female ,Risk assessment ,business ,Electrocardiography - Abstract
IMPORTANCE Little is known about the relationship between perioperative high-sensitivity troponin T (hsTnT) measurements and 30-day mortality and myocardial injury after noncardiac surgery (MINS). OBJECTIVE To determine the association between perioperative hsTnT measurements and 30-day mortality and potential diagnostic criteria for MINS (ie, myocardial injury due to ischemia associated with 30-day mortality). DESIGN, SETTING, AND PARTICIPANTS Prospective cohort study of patients aged 45 years or older who underwent inpatient noncardiac surgery and had a postoperative hsTnT measurement. Starting in October 2008, participants were recruited at 23 centers in 13 countries; follow-up finished in December 2013. EXPOSURES Patients had hsTnT measurements 6 to 12 hours after surgery and daily for 3 days; 40.4% had a preoperative hsTnT measurement. MAIN OUTCOMES AND MEASURES A modified Mazumdar approach (an iterative process) was used to determine if there were hsTnT thresholds associated with risk of death and had an adjusted hazard ratio (HR) of 3.0 or higher and a risk of 30-day mortality of 3% or higher. To determine potential diagnostic criteria for MINS, regression analyses ascertained if postoperative hsTnT elevations required an ischemic feature (eg, ischemic symptom or electrocardiography finding) to be associated with 30-day mortality. RESULTS Among 21 842 participants, the mean age was 63.1 (SD, 10.7) years and 49.1% were female. Death within 30 days after surgery occurred in 266 patients (1.2%; 95% CI, 1.1%-1.4%). Multivariable analysis demonstrated that compared with the reference group (peak hsTnT = 5 ng/L or hsTnT >= 65 ng/L) without an ischemic feature was associated with 30-day mortality (adjusted HR, 3.20; 95% CI, 2.37-4.32). Among the 3904 patients (17.9%; 95% CI, 17.4%-18.4%) with MINS, 3633 (93.1%; 95% CI, 92.2%-93.8%) did not experience an ischemic symptom. CONCLUSIONS AND RELEVANCE Among patients undergoing noncardiac surgery, peak postoperative hsTnT during the first 3 days after surgery was significantly associated with 30-day mortality. Elevated postoperative hsTnT without an ischemic feature was also associated with 30-day mortality.
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- 2017
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32. Correction: Comparison of Transversus Abdominis Plane Infiltration with Liposomal Bupivacaine versus Continuous Epidural Analgesia versus Intravenous Opioid Analgesia
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Ayad, Sabry, Babazade, Rovnat, Elsharkawy, Hesham, Nadar, Vinayak, Lokhande, Chetan, Makarova, Natalya, Khanna, Rashi, Sessler, Daniel I., and Turan, Alparslan
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Adult ,Male ,lcsh:Medicine ,Humans ,Pain Management ,Registries ,lcsh:Science ,Abdominal Muscles ,Aged ,Pain Measurement ,Retrospective Studies ,Pain, Postoperative ,Multidisciplinary ,Morphine ,Anti-Inflammatory Agents, Non-Steroidal ,lcsh:R ,Correction ,Analgesia, Patient-Controlled ,Length of Stay ,Middle Aged ,Bupivacaine ,Analgesia, Epidural ,Analgesics, Opioid ,Fentanyl ,Liposomes ,Female ,Steroids ,lcsh:Q ,Algorithms - Abstract
Epidural analgesia is considered the standard of care but cannot be provided to all patients Liposomal bupivacaine has been approved for field blocks such as transversus abdominis plane (TAP) blocks but has not been clinically compared against other modalities. In this retrospective propensity matched cohort study we thus tested the primary hypothesis that TAP infiltration are noninferior (not worse) to continuous epidural analgesia and superior (better) to intravenous opioid analgesia in patients recovering from major lower abdominal surgery. 318 patients were propensity matched on 18 potential factors among three groups (106 per group): 1) TAP infiltration with bupivacaine liposome; 2) continuous Epidural analgesia with plain bupivacaine; and; 3) intravenous patient-controlled analgesia (IV PCA). We claimed TAP noninferior (not worse) over Epidural if TAP was noninferior (not worse) on total morphine-equivalent opioid and time-weighted average pain score (10-point scale) within first 72 hours after surgery with noninferiority deltas of 1 (10-point scale) for pain and an increase less of 20% in the mean morphine equivalent opioid consumption. We claimed TAP or Epidural groups superior (better) over IV PCA if TAP or Epidural was superior on opioid consumption and at least noninferior on pain outcome. Multivariable linear regressions within the propensity-matched cohorts were used to model total morphine-equivalent opioid dose and time-weighted average pain score within first 72 hours after surgery; joint hypothesis framework was used for formal testing. TAP infiltration were noninferior to Epidural on both primary outcomes (p0.001). TAP infiltration were noninferior to IV PCA on pain scores (p = 0.001) but we did not find superiority on opioid consumption (p = 0.37). We did not find noninferiority of Epidural over IV PCA on pain scores (P = 0.13) and nor did we find superiority on opioid consumption (P = 0.98). TAP infiltration with liposomal bupivacaine and continuous epidural analgesia were similar in terms of pain and opioid consumption, and not worse in pain compared with IV PCA. TAP infiltrations might be a reasonable alternative to epidural analgesia in abdominal surgical patients. A large randomized trial comparing these techniques is justified.
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- 2016
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33. Nitrous oxide and risk of surgical wound infection: a randomised trial
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Fleischmann, Edith, Lenhardt, Rainer, Kurz, Andrea, Herbst, Friedrich, Fülesdi, Béla, Greif, Robert, Sessler, Daniel I., Akça, Ozan, Kanyári, Zsolt, and Orosz, László
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Male ,Nitrogen ,Remifentanil ,Nitrous Oxide ,Klinikai orvostudományok ,Asepsis ,law.invention ,chemistry.chemical_compound ,law ,Risk Factors ,Medicine ,Humans ,Surgical Wound Infection ,Colectomy ,Intention-to-treat analysis ,business.industry ,Surgical wound ,Orvostudományok ,General Medicine ,Nitrous oxide ,Middle Aged ,Intensive care unit ,Oxygen ,Isoflurane ,chemistry ,Bispectral index ,Anesthesia ,Anesthetics, Inhalation ,Female ,business ,medicine.drug - Abstract
Summary Background Nitrous oxide inactivates vitamin B12 and methionine synthase, thereby impairing DNA formation and, consequently, new cell formation. The gas also inhibits methionine production, which can reduce scar formation and depresses chemotactic migration by monocytes. Therefore, we assessed whether nitrous oxide increases the incidence of surgical wound infection. Methods We recruited 418 patients aged 18–80 years, scheduled for colon resection that was expected to last more than 2 h, at three hospitals in Austria and Hungary. Patients were randomly assigned 65% intraoperative nitrous oxide (n=208) or nitrogen (n=206), with remifentanil and isoflurane. The primary outcome was the incidence of clinical postoperative wound infection, analysed by intention to treat. Findings 206 patients in the nitrous oxide group and 202 in the nitrogen group were included in the final analysis. Duration of surgery was longer in the nitrogen group (3·4 h [1·5]) than in the nitrous oxide group (3·0 h [SD 1·3]) and arterial pressure (84 mm Hg [10] vs 81 mm Hg [9]), bispectral index values (53 [9] vs 44 [8]), and end-tidal isoflurane concentration (0·64% [0·14] vs 0·56% [0·13]) were greater in patients given nitrogen than in those given nitrous oxide. Infection rate was 15% (31/206) in patients given nitrous oxide and 20% (40/202) in those given nitrogen (p=0·205). Additionally, the ASEPSIS wound healing score, wound collagen deposition, number of patients admitted to critical care unit, time to first food ingestion, duration of hospital stay, and mortality did not differ between treatment groups. Interpretation Nitrous oxide does not increase the incidence of surgical wound infection.
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- 2005
34. Association Between Postoperative Troponin Levels and 30-Day Mortality Among Patients Undergoing Noncardiac Surgery
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Devereaux, P. J., Chan, Matthew T. V., Alonso-Coello, Pablo, Walsh, Michael, Berwanger, Otavio, Villar, Juan Carlos, Wang, C. Y., Garutti, R. Ignacio, Jacka, Michael J., Sigamani, Alben, Srinathan, Sadeesh, Biccard, Bruce M., Chow, Clara K., Abraham, Valsa, Tiboni, Maria, Pettit, Shirley, Szczeklik, Wojciech, Buse, Giovanna Lurati, Botto, Fernando, Guyatt, Gordon, Heels-Ansdell, Diane, Sessler, Daniel I., Thorlund, Kristian, Garg, Amit X., Mrkobrada, Marko, Thomas, Sabu, Rodseth, Reitze N., Rupert Pearse, Thabane, Lehana, Mcqueen, Matthew J., Vanhelder, Tomas, Bhandari, Mohit, Bosch, Jackie, Kurz, Andrea, Polanczyk, Carisi, Malaga, German, Nagele, Peter, Le Manach, Yannick, Leuwer, Martin, Yusuf, Salim, and Vasc Events Noncardiac Surg Patien
35. The Neurovision Pilot Study: Noncardiac Surgery Carries A Significant Risk Of Acute Covert Stroke
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Mrkobrada, Marko, Hill, Michael D., Chan, Matthew T., Sigamani, Alben, Cowan, David, Kurz, Andrea, Sessler, Daniel I., Michael Hill, Graham, Michelle M., O Donnel, Martin J., Dasgupta, Monidipa, Emery, Derek J., Gelb, Adrian W., Gulka, Irene, Heels-Ansdell, Diane, Guyatt, Gordon, Murkin, John, Sahlas, Demetrios J., Srinathan, Sadeesh, St John, Phil, Tsai, Scott S., Wendland, Emily, and Devereaux, P. J.
36. One-year Results of a Factorial Randomized Trial of Aspirin versus Placebo and Clonidine versus Placebo in Patients Having Noncardiac Surgery
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Patrice Forget, Joel L. Parlow, Christian S. Meyhoff, Yannick Le Manach, Alben Sigamani, Matthew T. V. Chan, Mohammed Amir, Giovanni Landoni, Bruce M Biccard, Alparslan Turan, Andrea Kurz, Denis Xavier, Richard P. Whitlock, Gordon H. Guyatt, Germán Málaga, Ekaterina Popova, Juan Carlos Villar, Andre Lamy, David Torres, Kate Leslie, Daniel I. Sessler, Priya A. Kumar, Kumar Balasubramanian, Ian Gilron, Sadeesh Srinathan, Marko Mrkobrada, Michelle M. Graham, Pilar Paniagua, Chew Yin Wang, Shirley Pettit, Edith Fleischmann, Salim Yusuf, Otavio Berwanger, Philip J. Devereaux, David Conen, Sessler, Daniel I, Conen, David, Leslie, Kate, Yusuf, Salim, Popova, Ekaterina, Graham, Michelle, Kurz, Andrea, Villar, Juan Carlo, Mrkobrada, Marko, Sigamani, Alben, Biccard, Bruce M, Meyhoff, Christian S, Parlow, Joel L, Guyatt, Gordon, Xavier, Deni, Chan, Matthew T V, Kumar, Priya A, Forget, Patrice, Malaga, German, Fleischmann, Edith, Amir, Mohammed, Torres, David, Wang, C Y, Paniagua, Pilar, Berwanger, Otavio, Srinathan, Sadeesh, Landoni, Giovanni, Manach, Yannick Le, Whitlock, Richard, Lamy, André, Balasubramanian, Kumar, Gilron, Ian, Turan, Alparslan, Pettit, Shirley, and Devereaux, P J
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Male ,Internationality ,Time Factors ,medicine.medical_treatment ,Myocardial Infarction ,Infarction ,030204 cardiovascular system & hematology ,Placebo ,Clonidine ,Perioperative Care ,03 medical and health sciences ,0302 clinical medicine ,Postoperative Complications ,medicine ,Humans ,030212 general & internal medicine ,Myocardial infarction ,Aged ,Aspirin ,Analgesics ,business.industry ,Hazard ratio ,Anti-Inflammatory Agents, Non-Steroidal ,Percutaneous coronary intervention ,Perioperative ,Middle Aged ,medicine.disease ,Anesthesiology and Pain Medicine ,Anesthesia ,Female ,business ,medicine.drug ,Follow-Up Studies - Abstract
Background The authors previously reported that perioperative aspirin and/or clonidine does not prevent a composite of death or myocardial infarction 30 days after noncardiac surgery. Moreover, aspirin increased the risk of major bleeding and clonidine caused hypotension and bradycardia. Whether these complications produce harm at 1 yr remains unknown. Methods The authors randomized 10,010 patients with or at risk of atherosclerosis and scheduled for noncardiac surgery in a 1:1:1:1 ratio to clonidine/aspirin, clonidine/aspirin placebo, clonidine placebo/aspirin, or clonidine placebo/aspirin placebo. Patients started taking aspirin or placebo just before surgery; those not previously taking aspirin continued daily for 30 days, and those taking aspirin previously continued for 7 days. Patients were also randomly assigned to receive clonidine or placebo just before surgery, with the study drug continued for 72 h. Results Neither aspirin nor clonidine had a significant effect on the primary 1-yr outcome, a composite of death or nonfatal myocardial infarction, with a 1-yr hazard ratio for aspirin of 1.00 (95% CI, 0.89 to 1.12; P = 0.948; 586 patients [11.8%] vs. 589 patients [11.8%]) and a hazard ratio for clonidine of 1.07 (95% CI, 0.96 to 1.20; P = 0.218; 608 patients [12.1%] vs. 567 patients [11.3%]), with effect on death or nonfatal infarction. Reduction in death and nonfatal myocardial infarction from aspirin in patients who previously had percutaneous coronary intervention at 30 days persisted at 1 yr. Specifically, the hazard ratio was 0.58 (95% CI, 0.35 to 0.95) in those with previous percutaneous coronary intervention and 1.03 (95% CI, 0.91to 1.16) in those without (interaction P = 0.033). There was no significant effect of either drug on death, cardiovascular complications, cancer, or chronic incisional pain at 1 yr (all P > 0.1). Conclusions Neither perioperative aspirin nor clonidine have significant long-term effects after noncardiac surgery. Perioperative aspirin in patients with previous percutaneous coronary intervention showed persistent benefit at 1 yr, a plausible sub-group effect. Editor’s Perspective What We Already Know about This Topic What This Article Tells Us That Is New
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- 2020
37. Methylprednisolone in patients undergoing cardiopulmonary bypass (SIRS): a randomised, double-blind, placebo-controlled trial
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Andre Lamy, Kevin Teoh, Jessica Vincent, Domenico Paparella, Hong Zheng, Ganesan Karthikeyan, Alvaro Avezum, Susan Chrolavicius, Pallav Shah, Salim Yusuf, Janice Pogue, Yunxia Zuo, Georgios I Tagarakis, Shirley Pettit, Mackenzie A. Quantz, Seyed Hesameddin Abbasi, Richard P. Whitlock, Daniel I. Sessler, Philip J. Devereaux, Juan Carlos Villar, Whitlock, Richard P., Devereaux, P. J., Teoh, Kevin H., Lamy, Andre, Vincent, Jessica, Pogue, Janice, Paparella, Domenico, Sessler, Daniel I., Karthikeyan, Ganesan, Villar, Juan Carlo, Zuo, Yunxia, Avezum, Álvaro, Quantz, Mackenzie, Tagarakis, Georgios I, Shah, Pallav J., Abbasi, Seyed Hesameddin, Zheng, Hong, Pettit, Shirley, Chrolavicius, Susan, Yusuf, Salim, and DE FEO, Marisa
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Male ,medicine.medical_specialty ,Placebo-controlled study ,Anti-Inflammatory Agents ,Placebo ,Methylprednisolone ,law.invention ,Randomized controlled trial ,Double-Blind Method ,law ,medicine ,Cardiopulmonary bypass ,Humans ,Aged ,Aged, 80 and over ,Intention-to-treat analysis ,Cardiopulmonary Bypass ,business.industry ,Medicine (all) ,General Medicine ,Middle Aged ,medicine.disease ,Systemic Inflammatory Response Syndrome ,Surgery ,Cardiac surgery ,Systemic inflammatory response syndrome ,Anesthesia ,Female ,business ,medicine.drug - Abstract
Summary Background Cardiopulmonary bypass initiates a systemic inflammatory response syndrome that is associated with postoperative morbidity and mortality. Steroids suppress inflammatory responses and might improve outcomes in patients at high risk of morbidity and mortality undergoing cardiopulmonary bypass. We aimed to assess the effects of steroids in patients at high risk of morbidity and mortality undergoing cardiopulmonary bypass. Methods The Steroids In caRdiac Surgery (SIRS) study is a double-blind, randomised, controlled trial. We used a central computerised phone or interactive web system to randomly assign (1:1) patients at high risk of morbidity and mortality from 80 hospital or cardiac surgery centres in 18 countries undergoing cardiac surgery with the use of cardiopulmonary bypass to receive either methylprednisolone (250 mg at anaesthetic induction and 250 mg at initiation of cardiopulmonary bypass) or placebo. Patients were assigned with block randomisation with random block sizes of 2, 4, or 6 and stratified by centre. Patients aged 18 years or older were eligible if they had a European System for Cardiac Operative Risk Evaluation of at least 6. Patients were excluded if they were taking or expected to receive systemic steroids in the immediate postoperative period or had a history of bacterial or fungal infection in the preceding 30 days. Patients, caregivers, and those assessing outcomes were masked to allocation. The primary outcomes were 30-day mortality and a composite of death and major morbidity (ie, myocardial injury, stroke, renal failure, or respiratory failure) within 30 days, both analysed by intention to treat. Safety outcomes were also analysed by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00427388. Findings Patients were recruited between June 21, 2007, and Dec 19, 2013. Complete 30-day data was available for all 7507 patients randomly assigned to methylprednisolone (n=3755) and to placebo (n=3752). Methylprednisolone, compared with placebo, did not reduce the risk of death at 30 days (154 [4%] vs 177 [5%] patients; relative risk [RR] 0·87, 95% CI 0·70–1·07, p=0·19) or the risk of death or major morbidity (909 [24%] vs 885 [24%]; RR 1·03, 95% CI 0·95–1·11, p=0·52). The most common safety outcomes in the methylprednisolone and placebo group were infection (465 [12%] vs 493 [13%]), surgical site infection (151 [4%] vs 151 [4%]), and delirium (295 [8%] vs 289 [8%]). Interpretation Methylprednisolone did not have a significant effect on mortality or major morbidity after cardiac surgery with cardiopulmonary bypass. The SIRS trial does not support the routine use of methylprednisolone for patients undergoing cardiopulmonary bypass. Funding Canadian Institutes of Health Research.
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