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Objective: To investigate the effect of day-case stapes surgery on hearing results, quality of life, patient satisfaction, and complications rates, compared with inpatient stapes surgery., Study Design: A single-center, nonblinded, randomized controlled trial in a tertiary referral center., Methods: One hundred twelve adult patients planned for primary or revision stapes surgery were randomly assigned to either the day-case or inpatient treatment group. The effect on hearing outcomes (primarily), hearing benefits, quality of life, patient satisfaction, postoperative complications, and causes of crossover or readmission (secondarily) were assessed using auditory evaluations, questionnaires, and patients' charts over a follow-up period of 1 year., Results: Audiometric measurements and postoperative success rates were not different between the inpatient and day-case group. There were no statistically significant differences between both groups regarding the overall quality of life (QoL) (HUI3), disease-specific QoL (GHSI), change in postoperative health status (GBI), and postoperative complications rate. We found a high patient satisfaction toward the day-case approach. Six patients allocated to the inpatient group requested same-day discharge. Of the day-case patients, there was a crossover rate to inpatient care of 38% (20 patients), mainly due to postoperative nausea and vomiting (25%), vertigo (20%), or dizziness (40%)., Conclusion: We found no significant differences in outcomes of audiometric measurements, QoL, patient satisfaction and postoperative complications following day-case, and inpatient stapes surgery. Therefore, stapes surgery in a day-case setting seems to be a feasible approach in terms of postoperative outcome, safety, and desirability when taking patient selection and surgical planning into account. Besides this, the familiarity with a day-case approach of both patient and the surgical team, will increase the acceptance and feasibility of day-case stapes surgery., Competing Interests: None declared., (Copyright © 2022 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of Otology & Neurotology, Inc.)

Background: Otosclerosis is characterized by bony deposits in the otic capsule, resulting in stapes fixation and progressive hearing loss. It can be treated effectively by surgically removing (part of) the stapes and replacing it with a prosthesis. Increasingly, stapes surgery is performed as a day-case procedure. The major drive towards day-case surgery has been out of economic considerations. However, it is also increasingly an explicit patient request and leads to shorter waiting times for surgery, a reduced risk of infection and most likely positively influences the patient's quality of life as a result of rapid discharge and rehabilitation. Even though stapes surgery seems well suited to a day-case approach, given the low complication rates and early recovery, evidence is scarce and of low quality., Methods and Design: A single-center unblinded randomized controlled trial was designed to (primarily) investigate the effect of hearing outcomes of day-case stapes surgery compared to inpatient stapes surgery and (secondarily) investigate the effect of both methods on quality of life, tinnitus, vertigo and cost-effectiveness. One hundred and twelve adult otosclerosis patients who are eligible for stapes surgery will be randomly assigned to either the day-case or inpatient treatment group. The primary and secondary outcome measures will be assessed using pure-tone audiometry (at approximately 2 months and 1 year follow-up), questionnaires (at 3 months and 1 year follow-up) and costs diaries (weekly the first month after which once a month until 1 year follow-up)., Discussion/conclusion: This trial allows for a comparison between day-case and inpatient stapes surgery to investigate the hypothesis that day-case stapes surgery is associated with a higher quality of life and higher cost-effectiveness, while maintaining equal hearing results, compared to inpatient stapes surgery., Trial Registration: Netherlands Trial Register (www.trialregister.nl): NTR4133, registration date 21(st) August 2013.

Objective: To study the pharmacokinetic behaviour of quinine in Caucasians with and without malaria., Method: Quinine-dihydrochloride was administered intravenously as a single dose of 300 mg to 12 healthy subjects and as multiple doses of 600 mg in 4 h every 8 h in 10 patients with falciparum malaria. Plasma quinine concentrations were measured by high-performance liquid chromatography, Results: Quinine pharmacokinetics are time-dependent: the apparent elimination halftime is shorter in the accumulation phase than in the elimination phase; in malaria patients the maximal quinine concentration was reached in half the time calculated on the basis of the elimination phase after the last quinine infusion. Nevertheless a loading dose seemed advisable to reach adequate therapeutic levels quickly. In malaria patients the highest plasma concentrations during or at the end of the infusions were positively correlated with body weight. There was no correlation between body weight and the volume of distribution of quinine as calculated during the elimination phase. Hearing loss was audiometrically documented in 9 healthy subjects at a mean maximal plasma quinine concentration of only 2 mg/l. All malaria patients suffered serious cochlear hearing impairment. The ototoxic effects in both healthy subjects and patients appeared to be reversible. No electrographic changes were noted in the healthy subjects, whereas a clinically insignificant mean lengthening of the corrected QT interval was seen in the malaria patients., Conclusion: Intravenous quinine pharmacokinetics in healthy Caucasians were similar to those reported for Nigerian or Thai subjects. At effective doses quinine causes considerable but reversible cochlear hearing losses in both healthy persons and in patients. Our findings do support the need for a loading dose. The fact that in malaria patients there was no correlation between body weight and quinine VD as calculated during the elimination phase renders questionable the usefulness of dosing quinine according to body weight.