Effect and safety of mivacurium chloride and succinylcholine for bronchoscopy: study protocol for a single-center, randomized, non-inferiority, and positive-controlled clinical trial

米伐库铵氯化物和琥珀酰胆碱用于支气管镜检查的效果和安全性:一项单中心、随机、非劣效性、阳性对照临床试验的研究方案

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Abstract

BACKGROUND: Succinylcholine is favored for its rapid onset and offset, but its use is limited by adverse effects. Mivacurium chloride, a non-depolarizing relaxant, offers a similar shorter duration and fewer cardiovascular effects, especially without worrying about muscle pain and hyperkalemia, making it a potential alternative in some short-time operations. This study aims to assess the non-inferiority of mivacurium chloride compared to succinylcholine in terms of muscle relaxation effect and safety during flexible bronchoscopy. METHODS: This is a prospective, single-center, randomized, assessor-blinded, positive-controlled trial. Participants scheduled for flexible bronchoscopy requiring muscle relaxation were randomly assigned to receive either mivacurium chloride or succinylcholine. The primary endpoint is the recovery rate of spontaneous breathing within 15 min after discontinuation of muscle relaxants. Other outcomes, including recovery time at different levels, hemodynamic changes, adverse events, and satisfaction from physicians and patients, are also collected. DISCUSSION: This study aims to compare the recovery effect of mivacurium chloride for muscle relaxation during bronchoscopy with succinylcholine, hypothesizing that mivacurium chloride is non-inferior in recovery time and superior in safety and comfort. TRIALS REGISTRATION: Chinese Clinical Trial Registry ChiCTR2400091276. Registered on 23 October 2024. CLINICALTRIALS: gov NCT06709066. Posted on 29 November 2024.

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