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临床试验/CTRI/2025/10/095880
CTRI/2025/10/095880尚未招募4 期

Effects of Sugammadex and Neostigmine-glycopyrrolate on postoperative Nausea and Vomiting in ENT Surgery

Nibedita Hazarika1 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2025年11月19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
148
试验地点
1
主要终点
To compare the effects of Sugammadex on post operative nausea and vomiting with those of Neostigmine glycopyrolate mixture during the first 24 hours

研究概览

简要总结

This is a prospective double blinded randomized control study to be conducted in the department of ENT major operation theatres of Gauhati  Medical  college and hospital under the department of Anaesthesiology and Critical care,GMCH.The study will be carried out on adult patients of both sexes posted for ENT surgery. The aim of the study is  to compare the effects of Sugammadex and Neostigmine glycopyrolate mixture as reversal agents on the incidence of post operative nausea and vomiting during the first 24 hours  following in ear, nose, throat surgery.The secondary objective of the study is to assess incidence of acute postoperative complications such as hemoglobin desaturation, tracheal re intubation  and unexpected I.C.U admission after reversal with Sugammadex or Neostigmine glycopyrolate mixturte.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor 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

  • 1.Patient undergoing elective ear,nose,throat surgeries under general anesthesia
  • ASA grade 1,2 3.Patient who have given written and informed consent 4.Patient with no history of PONV.

排除标准

  • 1.Emergency surgery 2.Pregnant female 3.ASA grade 3 and above 4.Patient with incapacity to consent 5.Patient requiring post operative ventilation 6.History suggestive of hypersensitivity to drugs used in the study 7.Patients with impaired renal function Patient with impaired renal function Patient who underwent middle ear surgery requiring nerve monitoring.

结局指标

主要结局

To compare the effects of Sugammadex on post operative nausea and vomiting with those of Neostigmine glycopyrolate mixture during the first 24 hours

时间窗: To compare the effects of Sugammadex on post operative nausea and vomiting with those of Neostigmine glycopyrolate mixture during the first 24 hours

次要结局

  • To assess incidence of acute post operative complications such as hemoglobin desaturation, tracheal re intubation and unexpected I.C.U admission after reversal with SUgammadex or Neostigmine glycopyrolate mixture(Within 24 hours)

研究者

发起方
Nibedita Hazarika
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Nibedita Hazarika

Gauhati medical college and hospital

研究点 (1)

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