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临床试验/CTRI/2024/05/068151
CTRI/2024/05/068151尚未招募4 期

Effect of Magnesium sulphate on Vecuronium induced neuromuscular blockade reversal using Neostigmine: A randomized, single-blind study

All India Institute of Medical Sciences, Deoghar1 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2024年6月10日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
154
试验地点
1
主要终点
To compare the duration of neuromuscular reversal time (by NMT monitoring) of magnesium sulphate and placebo groups.

研究概览

简要总结

Participants who are included in the study will undergo routine induction of general anaesthesia with endotracheal intubation. 15 minutes prior to induction of general anaesthesia, the "study drug" will be administered to the participant and monitored. General anaesthesia will be induced by Propofol as induction agent with Fentanyl as adjuvant and muscle relaxant Vecuronium, premedication with Midazolam. Neuromuscular monitoring will be done with Acceleromyography using NMT monitoring to record the Train-of-four count and Train-of-four ratio.

This study is being done to find effect of magnesium sulphate on neuromuscular reversal using neostigmine in a vecuronium induced patient undergoing general anaestheia.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 29.99 kg/sq metre
  • ASA physical status 1 and 2.

排除标准

  • Patient refusal
  • Hyper and hypomagnesemia
  • Pregnancy
  • Cardiac disease
  • Neuromuscular disease (myasthenia gravis, muscular dystrophy, upper motor neuron lesions)
  • Special group of population (notified tribals, jail inmates, etc).

结局指标

主要结局

To compare the duration of neuromuscular reversal time (by NMT monitoring) of magnesium sulphate and placebo groups.

时间窗: 15 minutes before intubation, 10 minutes before intubation, 5 minutes before intubation, Immediately after intubation, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and so on.

Parameters - 1. Train-of-four count (TOFC), 2. Train-of-four ratio (TOFR)

时间窗: 15 minutes before intubation, 10 minutes before intubation, 5 minutes before intubation, Immediately after intubation, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and so on.

次要结局

  • 1. To compare the shifting time from OT to PACU of the two groups(2. To compare the need of supplemental vecuronium dose requirement among the groups.)

研究者

发起方
All India Institute of Medical Sciences, Deoghar
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dipak Bhuyan

All India Institute of Medical Sciences, Deoghar

研究点 (1)

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