跳至主要内容
临床试验/CTRI/2025/03/082026
CTRI/2025/03/082026尚未招募Phase 3 4

Comparison of Effect of Intravenous Chlorpheniramine Maleate and Butorphanol as Premedication on Postoperative Agitation in Adult Patients Undergoing Otorhinolaryngeal Surgery.

Dr Amanjot Singh1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年3月18日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
To compare the post operative agitation in patients receiving preemptive intravenous chlorpheniramine maleate and butorphanol undergoing otorhinolaryngeal surgeries under GA.

研究概览

简要总结

Agitation with general anesthesia for otorhinolaryngeal surgeries was so frequent reaching up to 55.4%. Chlorpheniramine maleate a first-generation antihistaminic that antagonizes histamine H1-receptor. It is mainly used as an anti-allergic but has some anti-depressant and anti-anxiety actions, with unknown mechanism as well. Butorphanol is commonly used for the management of cancer, post-operative, gynecological, and obstetric pain. The main aim of the study is to compare the post operative agitation in patients receiving preemptive intravenous chlorpheniramine maleate and butorphanol undergoing otorhinolaryngeal surgeries under GA.The present study will be conducted in the department of Anaesthesiology, G.G.S.Medical College & Hospital, Faridkot on 80 patients belonging to ASA grade I & II, aged 18-65 years of either gender scheduled to undergo Otorhinolaryngeal surgeries. Patients will be randomly assigned into 2 equal groups. The first group (C) will receive chlorpheniramine maleate 5mg diluted in 9ml isotonic saline IV 15 minutes preinduction, second group (B) will receive butorphanol 1mg diluted in 9ml isotonic saline 15 minute preinduction.

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 65.00 Year(s)(—)
性别
All

入选标准

  • American Society of Anesthesiologists (ASA) grade I and II.

排除标准

  • Known allergy to chlorpheniramine maleate or/and butorphanol.
  • Patient with a history of neurological and psychiatric diseases.
  • Body mass index more than 30 of the ideal.
  • History of recent use of antihistaminic drugs.
  • Auditory or vision disorders Pregnancy.

结局指标

主要结局

To compare the post operative agitation in patients receiving preemptive intravenous chlorpheniramine maleate and butorphanol undergoing otorhinolaryngeal surgeries under GA.

时间窗: 30 min after surgery

次要结局

  • To assess the post operative agitation in patient receiving preemptive intravenous chlorpheniramine maleate undergoing Otorhinolaryngeal surgery under GA.(To assess the post operative agitation in patient receiving preemptive intravenous butorphanol undergoing Otorhinolaryngeal surgery under GA.)

研究者

发起方
Dr Amanjot Singh
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Amanjot singh

GGSMCH,Faridkot

研究点 (1)

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