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Compared efficacy and tolerance of the neuromuscular blockade induced by brand-name (Nimbex®) and generic (Cisatrex®) of cisatracurium in mechanically ventilated critically ill patients: a crossover double-blind randomized study.
- Source :
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The Pan African medical journal [Pan Afr Med J] 2020 Dec 15; Vol. 37, pp. 346. Date of Electronic Publication: 2020 Dec 15 (Print Publication: 2020). - Publication Year :
- 2020
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Abstract
- Introduction: use of generic drugs is common. However, there is still concern among patients and physicians that brand name drugs are more efficient. The aim of the study was to compare efficacy and tolerance between two forms of cisatracurium: brand name versus generic name.<br />Methods: it´s a crossover, randomized, double-blind physiological trial. Patients admitted for hypoxemic acute respiratory failure with PaO2/FIO2 < 200mmHg despite optimized ventilation and sedation thus requiring non-depolarizing neuromuscular blocking agents (NMBAs), were enrolled. Patients received consecutively, in a random order, cisatracurium brand name (Nimbex®) and generic (Cisatrex®) over two-hour period separated by one-hour washout period. Neuromuscular function was monitored by a calibrated train-of-four (TOF) stimulation device. Paralysis time delay to reach TOF of 2/4, recovery kinetics and tolerance were monitored. The number needed to demonstrate a significant difference in time delays to reach a TOF of 2/4 between the two forms of cisatracurium was estimated at 22 patients.<br />Results: twenty-two patients were included. Eight (36.4%) had acute respiratory distress syndrome; 8(36.4%), acute exacerbation of chronic obstructive pulmonary disease and 3(13.6%), status asthmaticus. Median [IQR] SAPS II at admission, 28.5 [22, 41]. PaO2/FIO2, 121 [81, 156] mmHg. Paralysis time delays were respectively, 80 [50, 112] vs. 87 [65, 115] minutes, in Nimbex® group and Cisatrex® group; (p=0.579). Within the recovery period, the between two-studied drugs´ difference in TOF was at 0.25±0.96; p=0.64. There were no significant hemodynamic differences.<br />Conclusion: the present study revealed no significant differences in efficacy nor in tolerance between cisatracurium brand name Nimbex® and generic name Cisatrex® in hypoxemic ventilated patients.<br />Competing Interests: The authors declare no competing interests.<br /> (Copyright: Nesrine Fraj et al.)
- Subjects :
- Acute Disease therapy
Adult
Atracurium administration & dosage
Atracurium adverse effects
Critical Illness
Cross-Over Studies
Double-Blind Method
Drugs, Generic administration & dosage
Drugs, Generic adverse effects
Female
Humans
Male
Middle Aged
Neuromuscular Blocking Agents adverse effects
Neuromuscular Monitoring methods
Respiratory Insufficiency
Atracurium analogs & derivatives
Neuromuscular Blockade methods
Neuromuscular Blocking Agents administration & dosage
Respiration, Artificial
Subjects
Details
- Language :
- English
- ISSN :
- 1937-8688
- Volume :
- 37
- Database :
- MEDLINE
- Journal :
- The Pan African medical journal
- Publication Type :
- Academic Journal
- Accession number :
- 33738034
- Full Text :
- https://doi.org/10.11604/pamj.2020.37.346.24986