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临床试验/CTRI/2024/11/076218
CTRI/2024/11/076218尚未招募2/3 期

To compare the frequency of perioperative respiratory adverse events using sugammadex versus neostigmine following functional endoscopic sinus surgery

Sri Guru Ram Das Institute of Medical Sciences and Research1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年11月8日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
The primary outcome of the study is to assess the frequency of

研究概览

简要总结

Introduction : Functional endoscopic sinus surgery (FESS) is a common procedure for managing sinus disorders, including chronic rhinosinusitis. Successful FESS not only relies on surgical technique but also on postoperative recovery, particularly neuromuscular function restoration and airway protection. Residual Neuromuscular Blockade (NMB) poses risks like airway obstruction and hypoxia, emphasizing the need for faster recovery. Sugammadex accelerates NMB reversal, reducing the risk of residual paralysis compared to neostigmine. This study aims to compare perioperative adverse events post-NMB reversal with sugammadex versus neostigmine in FESS patients. Aim: To compare the frequency of Perioperative respiratory adverse events (PRAE) using sugammadex or neostigmine as neuromuscular reversing agent following Functional Endoscopic Sinus Surgery (FESS). Objectives: To calculate and compare the frequency of Perioperative respiratory adverse events, Time to recovery of neuromuscular function and Hemodynamic Variation using sugammadex or neostigmine as a reversal agent after FESS surgery. Methodology : This randomized, controlled, prospective, double-blinded study will be conducted in 70 patients (aged 20-70 years) scheduled for Functional Endoscopic Sinus Surgery. The patients will be randomly allocated into two groups (35 patients each) to receive neuromuscular blockade reversal agent accordingly - Group A: Sugammadex 4 mg/kg intravenous; Group B: Neostigmine 0.05mg/kg + Glycopyrrolate 0.4mg intravenous. The frequency of Perioperative respiratory adverse events, time to recovery of neuromuscular function and hemodynamic variations will be noted and compared in the two groups. Significance of the study : This study seeks to enhance neuromuscular blockade reversal in Functional Endoscopic Sinus Surgery (FESS) by comparing Sugammadex and Neostigmine, crucial for patient safety and surgical success. Assessing their effectiveness, reversal speed, residual blockade incidence, and safety profile is vital for informed clinical decisions and better patient outcomes.

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 75.00 Year(s)(—)
性别
All

入选标准

  • 1.ASA physical status I and II 2.Patients undergoing functional endoscopic sinus surgery.

排除标准

  • 1.Known hypersensitivity to study drugs
  • History of any Respiratory disorder or Respiratory Tract Infection
  • History of drug abuse or Smoking
  • Serum creatinine more than 1.5 mg per dl.

结局指标

主要结局

The primary outcome of the study is to assess the frequency of

时间窗: at the time of extubation

Perioperative respiratory adverse events following Functional Endoscopic Sinus

时间窗: at the time of extubation

Surgery.

时间窗: at the time of extubation

次要结局

  • 1. Time to recovery of neuromuscular function(2. Hemodynamic Variation)

研究者

发起方
Sri Guru Ram Das Institute of Medical Sciences and Research
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Gaganjot Kaur

Sri Guru Ram Das Institute of Medical Sciences and Research

研究点 (1)

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