跳至主要内容
临床试验/CTRI/2024/12/078585
CTRI/2024/12/078585尚未招募4 期

Comparison study of time to recovery by sugammadex vs neostigmine for vecuronium reversal in patients undergoing laparoscopic cholecystectomy A Randomized controlled trail.

Aarupadai veedu medical College nd hospital1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2025年1月5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
74
试验地点
1
主要终点
To compare the Time to recovery provided by Sugammadex and Neostigmine in Vecuronium

研究概览

简要总结

Acetylcholinesterase inhibitors such as Neostigmine, have traditionally been used for reversal of Neuromuscular blockade by Non depolarizing Neuromuscular blocking agents. However, these drugs have significant limitations such as inability to reverse profound and deep blockade (due to the ceiling effect of these agents), resulting in incomplete reversal and residual blockade, cardiovascular adverse effects, and undesirable autonomic responses.

Sugammadex is a modified γ-cyclodextrin works by encapsulating the molecules of the neuromuscular blockade agents Its unique mechanism of action is responsible for the rapid and efficient reversal of the deep neuromuscular blockade, without autonomic cholinergic side effects.

So we are comparing Time to recovery provided by Sugammadex and Neostigmine in Vecuronium induced Neuromuscular blockade in patient undergoing laparoscopic cholecystectomy.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • Age : 18 to 65 years
  • ASA I, ASA II and ASA III
  • Elective Laparoscopic cholecystectomy surgery 4.

排除标准

  • 1.Patients with neuromuscular diseases 2.Patients using medications that influence neuromuscular functions (e.g:-Calcium channel blockers, magnesium supplements , phenytoin, amino glycoside) 3.Electrolytes abnormalities 4.Hepatic or renal insufficiency 5.Patients with known allergies to medications used in the study 6.Laparoscopic cholecystectomy converted to open surgery.

结局指标

主要结局

To compare the Time to recovery provided by Sugammadex and Neostigmine in Vecuronium

时间窗: 5 min

induced Neuromuscular blockade in patient undergoing laparoscopic cholecystectomy.

时间窗: 5 min

次要结局

  • To moniter Hemodynamics changes with extubation.(4 hrs)
  • To moniter for any Residual neuromuscular blockade.(6 hrs)

研究者

发起方
Aarupadai veedu medical College nd hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr S Praveen kumar

Aarupadai veedu medical College and hospital

研究点 (1)

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