跳至主要内容
临床试验/CTRI/2023/08/056990
CTRI/2023/08/056990尚未招募不适用

To compare the efficacy of magnesium sulphate gargles and ketamine gargles on incidence and severity of post-operative sore throat following endotracheal intubation.

Dr. Ramesh Kumar P B1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年4月9日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
Post-operative sore throat

研究概览

简要总结

Post-operativesore throat (POST) is a common adverse event after general anaesthesia. Thoughconsidered as a minor complication, it may cause significant post-operativemorbidity and patient dissatisfaction. Ketamine, an NMDA receptor antagonist,has been used as gargle, for reducing the incidence and severity of POSTfollowing endotracheal intubation. Magnesium sulphate, also an NMDA receptorantagonist has been recently used as gargle and found to attenuate POST moresignificantly than ketamine.This comparison has been made in patients in whomairway was secured using endotracheal tube. Our study was aimed at assessingand comparing the efficacy of magnesium sulphate and ketamine gargles onincidence and severity of post-operative sore throat following endotrachealintubation.

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

  • Patients requiring general anaesthesia with Proseal laryngeal mask airway.
  • Physical status ASA grade I and II.

排除标准

  • 1.Patients with history of pre-operative sore throat, asthma, COPD.
  • 2.Patients requiring oropharyngeal, head and neck surgeries.
  • 3.Patients with Body Mass Index > 30 kg/m
  • 4.Patients with full stomach or abdominal distension.
  • 5.Patients with gastroesophageal reflux disease.
  • 6.Patients with modified mallampatti class IV, anticipated difficult airway.
  • 7.Patients having allergy to study drugs.
  • 8.Patients who have recently received NSAIDS.
  • 9.Patients having nausea and vomiting.
  • 10.Expected duration of surgery more than 2 hours.

结局指标

主要结局

Post-operative sore throat

时间窗: Assessed at 0, 2, 4, 24 hrs post-operatively & graded on a four-point scale

次要结局

  • Requirement of Analgesics for POST & Side Effects profile of study drugs.(VAS scoring POST to be assessed at 0,2,6,24 hours post operatively)

研究者

发起方
Dr. Ramesh Kumar P B
申办方类型
Other [self]

研究点 (1)

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