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临床试验/NCT01996358
NCT01996358暂停不适用

Comparing Intubating Conditions Using Succinylcholine or Rocuronium/Sugammadex for Rigid Bronchoscopy: a Randomized Study

Dr. Horst Schmidt Klinik GmbH1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2015年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
暂停
发起方
入组人数
150
试验地点
1
主要终点
Intubating Condition

研究概览

简要总结

Succinylcholine is commonly used for neuromuscular relaxation for short procedures such as rigid bronchoscopy. A more modern alternative is the application aof rocuronium, reversed by sugammadex. The investigators compare the intubating conditions, incidence of postoperative myalgia (POM) as well as patient satisfaction for these two muscle relaxants.

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

入选标准

  • age > 18 yr
  • scheduled for elective rigid bronchoscopy

排除标准

  • known neuromuscular disease
  • significant hepatic or renal dysfunction
  • family history of malignant hyperthermia
  • known allergy to one of the drugs used in this protocol
  • pregnancy or breastfeeding

研究组 & 干预措施

Succinylcholine

Active Comparator

Succinylcholine 0,5mg/kg as muscle relaxant during induction of anaesthesia for rigid bronchoscopy

干预措施: Succinylcholine (Drug)

Rocuronium 0,3

Active Comparator

Rocuronium 0,3 mg/kg during induction of anaesthesia for rigid bronchoscopy. At the end of procedure 2mg/kg sugammadex for reversal of neuromuscular block are applied.

干预措施: Rocuronium 0,3 (Drug)

Rocuronium 0,6

Active Comparator

Rocuronium 0,6 mg/kg during induction of anaesthesia for rigid bronchoscopy. At the end of procedure 2mg/kg sugammadex for reversal of neuromuscular block are applied.

干预措施: Rocuronium 0,6 (Drug)

结局指标

主要结局

Intubating Condition

时间窗: after induction of general anaesthesia (after 3-5 minutes)

The intubating conditions will be measured using the scoring system proposed for Good Clinical Research Practice using the following variables: conditions of inserting the rigid bronchoscope, vocal cord position and coughing

次要结局

  • Postoperative Myalgia(72 hours after intervention)

研究者

发起方
Dr. Horst Schmidt Klinik GmbH
申办方类型
Industry
责任方
Principal Investigator
主要研究者

Prof. Grietje Beck

Professor Dr. med

Dr. Horst Schmidt Klinik GmbH

研究点 (1)

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