跳至主要内容
临床试验/CTRI/2025/06/089009
CTRI/2025/06/089009招募中不适用

Comparison of Neostigmine-glycopyrrolate and sugammadex as reversal agents in laparoscopic surgeries

Ruby Hall Clinic1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年6月28日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Assess the post operative residual paralysis in both groups using TOF, clinical assessment and ultrasound

研究概览

简要总结

comparison of neostigmine-glycopyrrolate and sugammadex as reversal agents in laparoscopic surgeries. all perioperative conditions kept identical.computer generated randomization list will be followed while administering reversal agents. Investigator and participant will be blinded.Thickening fraction of internal oblique and diaphragm will be intially measured and also repeated 30 minutes after extubation. Three TOF readings are taken before extubation and 15,30 and 45 minutes after extubation.Also time to achieve TOF 0.9 after administering reversal agent is also noted.Clinical signs like headlift, tongue protrusion and cough reflex are noted during extubation and in post operative period.Adverse effects like bronchospasm, hypoxia, bradycardia, respiratory distress and PONV are also noted

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator 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

  • 1.ASA 1/2 cases
  • BMI-18-26 3.No contraindication for receiving rocuronium 4.Laparoscopic surgeries lasting upto 2-3 hrs.

排除标准

  • 1.Allergy to rocuronium, sugammadex or neostigmine 2.malignant hyperthermia 3.hepatic or renal insufficiency 4.neuromuscular diseases 5.inability to give consent 6.Head, neck-face surgeries, thoracic and open abdominal surgeries.

结局指标

主要结局

Assess the post operative residual paralysis in both groups using TOF, clinical assessment and ultrasound

时间窗: 3 readings of TOF pre extubation | 3 readings of TOF post extubation at 15, 30 and 45 minutes | Clinical assessment at same time points | respiratory muscle assessment by sonography at 30 minutes

次要结局

  • Adverse events in either group(Group 1/ N: Neostigmine (2.5mg)-glyco (0.4mg) for reversal)

研究者

申办方类型
Private hospital/clinic

研究点 (1)

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