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临床试验/CTRI/2024/06/068258
CTRI/2024/06/068258招募中Unknown

A comparison of sugammadex and neostigmine for rapidity and smoothness of reversal of neuromuscular blockade in patient undergoing excision of intracranial space-occupying lesions. A prospective randomized, double-blind, single-center study

Life Line Hospital and Research Centre1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年6月11日最近更新:

试验速览

阶段
Unknown
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Comparison of rapidity of reversal from neuromuscular blockade by using Sugammadex versus Neostigmine based on train of four ratio 0.8

研究概览

简要总结

During reversal from the neuromuscular agent at the end of the surgery, hypertension, coughing, and bucking are avoided while the patient remains on the endotracheal tube because they can cause intracranial bleeding or a rise in ICP. The longer duration of recovery time increases these risks. Scondarily, It is essential to have the neurosurgical patient awake and responsive after surgery, allowing early neurologic assessment. This study is a randomized, double-blind, parallel, single-center comparing the rapid and smooth recovery of neuromuscular blockade using Sugammadex versus Neostigmine in 100 adult patients undergoing elective craniotomies. The primary outcome measures time is taken from administrating the reversal agent based on a train of four ratio of 0.8 to extubation. It also includes the additional anesthetic adjuvents used for smooth recovery. The secondary outcome measures the time taken for the modified Aldrete score to reach 9/10 after extubation, hemodynamic events, and complications until 1 hour from administrating the reversal agent.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Elective Craniotomies pertaining to Intracranial space occupying lesions
  • ASA II to III.

排除标准

  • Refusal to consent
  • Pediatric age group
  • Allergies to Study Drug
  • Neuro-degenerative, neuromuscular disorders
  • Pregnancy
  • Emergency surgery.

结局指标

主要结局

Comparison of rapidity of reversal from neuromuscular blockade by using Sugammadex versus Neostigmine based on train of four ratio 0.8

时间窗: Starting from administration of reversal agent till extubation

次要结局

  • Comparing hemodynamic events after reversal with sugammadex versus neostigmine(till two hour after extubation)
  • Secondary complication after reversal with sugammadex versus neostigmine(Till two hours after extubation)
  • Comparison of recovery from neuromuscular blockade using sugammadex versus neostigmine(Time taken to achieve modified Aldrete score of 9/10 after extubation)

研究者

发起方
Life Line Hospital and Research Centre
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Dr Gayatri Kumari

Life Line Hospital and Research Centre, Azamgarh

研究点 (1)

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