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临床试验/NCT02502032
NCT02502032已完成3 期

Effects of Pretreatment With Different Doses of Cisatracurium on Succinylcholine-induced Fasciculations

Zhuan Zhang0 个研究点目标入组 87 人开始时间: 2015年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
87
主要终点
Presence of fasciculations

研究概览

简要总结

To investigate the effects of different doses of cisatracurium pretreatment on succinylcholine-induced fasciculations.

详细描述

Ninety patients scheduled for laparoscopic cholecystectomies were equally randomized into three groups to receive pretreatment of 0.005, 0.01, and 0.02 mg/kg cisatracurium, respectively. General anesthesia was induced 3.5 min later, train of four stimulation was monitored 4.5 min later, succinylcholine 1.5 mg/kg was injected 5 min later, and endotracheal intubation was implemented 6.5 min later. The side effects of cisatracurium, intensity of fasciculations, intubating conditions, time and extent to maximal depression of twitch and time for its recovery to 20% of control value, severity of myalgia at 24 h postoperatively, serum potassium before cisatracurium pretreatments, at intubating time, and 5 min after intubation were recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Standards Association (ASA) physical status I or II patients scheduled for elective laparoscopic cholecystectomies with tracheal intubation requiring general anesthesia;
  • 20 - 65 years old;
  • Without acid-base imbalance and electrolyte disturbance;
  • With normal hepatic and renal function.

排除标准

  • Patients with the contraindications associated with succinylcholine or cisatracurium;
  • Patients taking drugs known to alter the action of neuromuscular blockers;
  • Patients with a body mass index exceeding 30

研究组 & 干预措施

Cisatracurium 0.005 mg/kg

Experimental

The group received pretreatment of cisatracurium 0.005 mg/kg.

干预措施: Cisatracurium (Drug)

Cisatracurium 0.01 mg/kg

Experimental

The group received pretreatment of cisatracurium 0.01 mg/kg.

干预措施: Cisatracurium (Drug)

Cisatracurium 0.02 mg/kg

Experimental

The group received pretreatment of cisatracurium 0.02 mg/kg.

干预措施: Cisatracurium (Drug)

结局指标

主要结局

Presence of fasciculations

时间窗: After the injection of succinylcholine for 1.5 minutes

次要结局

  • Side effects of the pretreatment of cisatracurium(From the time of 3 minutes after the pretreatment of cisatracurium for 0.5 minutes)
  • The time to maximal depression of twitch(From the time of 4.5 minutes after the pretreatment of cisatracurium for two minutes)
  • The extent to maximal depression of twitch(From the time of 4.5 minutes after the pretreatment of cisatracurium for two minutes)
  • The grades of endotracheal intubation(At intubating time)
  • The changes of serum potassium(After entering the operating theater till the anesthesia induction, at intubating, and 5 min after intubation)
  • Myalgia at 24 hours postoperatively(At 24 hours postoperatively)

研究者

发起方
Zhuan Zhang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zhuan Zhang

MD

Yangzhou No.1 People's Hospital

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