跳至主要内容
临床试验/CTRI/2021/08/035869
CTRI/2021/08/035869尚未招募不适用

A Randomised Double-blind Study to Compare the Intubating Conditions of Cisatracurium and Rocuronium for Intubation

Malankara Orthodox Syrian Church Medical College1 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2021年8月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
216
试验地点
1
主要终点
Onset time and intubating conditions of Cisatracurium and Rocuronium based on TOF stimuli and Copper Grading system respectively

研究概览

简要总结

Neuromuscular blockers are commonly used in general anaesthesia for endotracheal intubation and for providing muscle relaxation intraoperatively. An ideal neuromuscular blocking agent needs to take the shortest time to provide muscle relaxation for laryngoscopy and endotracheal intubation and furnish the best intubating conditions. Such drugs are especially useful in rapid sequence intubation in emergencies in the presence of a full stomach or conditions with an increased risk of aspiration.

Rocuronium bromide is an aminosteroid non-depolarizing neuromuscular blocker. It has become one of the most popular non-depolarizing neuromuscular blockers in clinical anesthesia due to its rapid onset of action. It becomes handy for rapid sequence intubation where succinylcholine is contraindicated. But it has the disadvantage that it accumulates in renal failure.

Cisatracurium is a stereoisomer of a nondepolarizing neuromuscular blocker Atracurium and has an intermediate duration of action. Cisatracurium undergoes Hoffmann degradation and produces the metabolite Laudanosine.

This study is planned to find out if Cisatracurium can be used as an alternative to Rocuronium for rapid sequence intubation by comparing the onset time of the drugs in the given doses, intubating conditions, the duration of action of the drugs in the given doses, and hemodynamic parameters.

STUDY HYPOTHESIS :

There is no significant difference in the onset time and intubating conditions between Cisatracurium and Rocuronium for intubation.

There is no difference in the duration of action of Cisatracurium and Rocuronium in the dose used.

There is no significant difference in the hemodynamic parameters between Cisatracurium and Rocuronium.

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研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
Female

入选标准

  • All patients undergoing surgeries requiring general anesthesia (procedures requiring general anesthesia for one hour or more). ASA Status of I and II. BMI between 20.

排除标准

  • Patients with anticipated difficult intubation.
  • Chronic alcoholics.
  • Patients with diseases affecting neuromuscular transmission.
  • Patients on medications known to interfere with neuromuscular blockers.

结局指标

主要结局

Onset time and intubating conditions of Cisatracurium and Rocuronium based on TOF stimuli and Copper Grading system respectively

时间窗: Assessed at 30 seconds interval

次要结局

  • Hemodynamic parameters between the two drugs are compared.(Duration of action of the two drugs in the given doses are compared.)

研究者

申办方类型
Private medical college

研究点 (1)

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