Phase 4 Study of Succinylcholine Versus Rocuronium as Neuromuscular Blocking Agent for Emergency Intubation in Intensive Care
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- Number of Participants Exhibiting Desaturation >5%
研究概览
简要总结
Emergency intubation of patients in intensive care is a high-risk endeavour. For many decades, succinylcholine has been the neuromuscular blocking agent of choice. However, succinylcholine may have life-threatening side effects and is contraindicated in a variety of diseases relevant in intensive care. The nondepolarizing agent rocuronium has been propagated as alternative for succinylcholine. Though a recent meta-analysis found no difference in intubating conditions between succinylcholine and rocuronium in elective cases, there are no data in emergent cases in intensive care. The aim of the present study is to compare succinylcholine and rocuronium with regard to 1) quality of intubating conditions, 2) length of the intubating sequence, 3) failed intubating attempts, 4) hemodynamic sequelae of intubation, and 5) desaturations.
详细描述
Objective
to compare succinylcholine and rocuronium with regard to 1) quality of intubating conditions, 2) length of the intubating sequence, 3) failed intubating attempts, 4) hemodynamic sequelae of intubation, and 5) desaturations.
Design: prospective, randomized, single-blind study. Setting: Intensive care units of an University Hospital. Patients: adult patients in intensive care requiring emergency intubation. Randomization: 1:1 randomization to either succinylcholine (1mg/kg) or rocuronium (0.6 mg/kg).
Data: 1) assessment of the quality of intubating conditions by means of a score, 2) length of the intubating sequence defined as time between injection of neuromuscular blocking agent and first end-tidal CO2 on the monitor, 3) number of failed intubating attempts, 4) hemodynamic sequelae of intubation, defined as events requiring injection of vasoactive drugs, and 5) desaturations, defined as saturation below 90% and/or any decrease in saturation of 5% or more.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •indication for emergency intubation in intensive care
- •availability of qualified study physician
排除标准
- •contraindication against succinylcholine or rocuronium
- •indication for awake fibreoptic intubation
研究组 & 干预措施
Succinylcholine
干预措施: Succinylcholine (Drug)
Rocuronium
干预措施: Rocuronium (Drug)
结局指标
主要结局
Number of Participants Exhibiting Desaturation >5%
时间窗: at any time between the start of the intubation sequence and 2min after the completion of intubation
decrease of \>5% in oxygen saturation measured continuously using pulse oxymetry
次要结局
- Haemodynamic Sequelae of Intubation(between start of induction sequence and 5 min after completion of intubation)
- Time to Completion of Intubation(time interval between the injection of the induction agent and the first appearance of endtidal CO2)
- Quality of Intubation Conditions Using a Validated Score: Viby-Mogensen et al. Good Clinical Research Practice (GCRP) in Pharmacodynamic Studies of Neuromuscular Blocking Agents. Acta Anaesthesiol Scand 1996;40:59-74.(during laryngoscopy and the first minute after completion of intubation)
- Number of Participants With an Failed First Intubation Attempts(within the first 90 sec following the start of induction)
研究者
Stephan Marsch
Professor and Chairman of Medical ICU
University Hospital, Basel, Switzerland