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临床试验/NCT02481193
NCT02481193已完成3 期

Effects of Cisatracurium on Succinylcholine-induced Fasciculations and Myalgia

Yangzhou No.1 People's Hospital0 个研究点目标入组 90 人开始时间: 2013年3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
90
主要终点
The presence of fasciculations

研究概览

简要总结

The purpose of this study is to investigate the effects of different doses of cisatracurium pretreatment on succinylcholine-induced fasciculations and postoperative myalgia.

详细描述

Purpose: To investigate the effects of different doses of cisatracurium pretreatment on succinylcholine-induced fasciculations and postoperative myalgia.

Methods: 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 the induction, at the time of endotracheal intubation, 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 known hyperkalemia
  • Patients with increased intraocular pressure
  • Patients with increased intracranial pressure
  • Patients with symptoms of gastroesophageal reflux
  • Patients with anticipated airway difficulties
  • Patients with malignant fever
  • Patients with neuromuscular disease
  • Patients with burn or crush injuries
  • Patients with taking drugs known to alter the action of neuromuscular blockers
  • Patients with 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

The 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(At the time of three minutes after the pretreatment of cisatracurium)
  • 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 time for twitch recovery to 20% of its control value(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
Yangzhou No.1 People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dongsheng Zhang, MD

MD

Yangzhou No.1 People's Hospital

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