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临床试验/CTRI/2025/11/097036
CTRI/2025/11/097036尚未招募不适用

A clinical double-blind randomized controlled study comparing the efficacy of Sugammadex in reversing Vecuronium-induced neuromuscular blockade in patients pretreated with Magnesium Sulphate(MgSO4).

未提供1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
150
试验地点
1
主要终点
To compare and evaluate the efficacy of pre-treatment with Magnesium

研究概览

简要总结

This prospective, double blind, randomized controlled study will be conducted to evaluate the efficacy of sugammadex in reversing vecuronium-induced neuromuscular blockade in patients who will be pretreated with magnesium sulphate . Eligible adult patients undergoing elective surgical procedures under general anesthesia will be randomly allocated into two groups. The study group will receive intravenous Magnesium Sulphate at a dose of 60 mg per kg before induction, while the control group will receive an equal volume of normal saline. Anesthesia will be induced with propofol and an opioid, followed by vecuronium 0.1 mg/kg to achieve adequate muscle relaxation. Continuous neuromuscular monitoring using Train of Four  stimulation will be utilized throughout the procedure. When the second twitch of the TOF reappears, sugammadex will be administered intravenously at a dose of 2 mg per kg . The primary endpoint will be the time from administration of sugammadex to recovery of a TOF ratio of 0.9 or greater, while secondary outcomes will include hemodynamic stability and occurrence of any adverse effects. This study will aim to determine whether pretreatment with magnesium sulphate influences the speed or effectiveness of reversal of vecuronium induced neuromuscular block by sugammadex.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

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

入选标准

  • ASA Grade 1 and 2.

排除标准

  • 未提供

结局指标

主要结局

To compare and evaluate the efficacy of pre-treatment with Magnesium

时间窗: The time taken to reach a train-of-four (TOF) ratio greater than 0.9 after administering Sugammadex.

Sulphate vs Normal saline in Vecuronium-induced neuromuscular blockade

时间窗: The time taken to reach a train-of-four (TOF) ratio greater than 0.9 after administering Sugammadex.

(train-of four (TOF) more than 0.9) on the time of reversal with Sugammadex.

时间窗: The time taken to reach a train-of-four (TOF) ratio greater than 0.9 after administering Sugammadex.

次要结局

  • To evaluate the post-operative complication of both groups(5 minutes post op)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Nilaoli A

Subharti Medical College and Hospitals

研究点 (1)

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