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临床试验/CTRI/2025/09/094760
CTRI/2025/09/094760尚未招募1 期

A Randomised Clinical Trial Comparing the Impacts of Magnesium Sulphate and Ketamine Spray on the Incidence and Severity of Sore Throat following intubation in Patients Under General Anaesthesia

CHRISTIAN MEDICAL COLLEGE1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2025年9月30日最近更新:

试验速览

阶段
1 期
状态
尚未招募
入组人数
140
试验地点
1
主要终点
To compare the effectiveness of magnesium and ketamine spray in reducing the incidence and severity of postoperative sore throat.

研究概览

简要总结

Post-operative sore throat refers to irritation or pain in the throat that occurs within 15 minutes to 24 hours after the extubation phase. The incidence of POST has been estimated to range from 6.6% to 90% following tracheal intubation, while the incidence is lower after LMA insertion (17.5%).  POST is one of the major causes of patient dissatisfaction and discharge delays following ambulatory surgery. Routine tracheal intubation for elective surgical procedures can lead to pathological changes, trauma, and nerve damage, which may contribute to postoperative throat symptoms. Various medications, including ketamine, lidocaine, budesonide, dexamethasone, and magnesium sulphate, have been administered via nebulisation, gargling, or intravenous routes to alleviate this issue in different institutions.

While numerous protocols have been proposed to prevent post-operative sore throat (POST), few have attracted significant interest. Various pharmacological and nonpharmacological methods have been explored to decrease POST incidence. Standard treatments include multimodal analgesia and adjuncts such as NSAIDs, lidocaine, and beclomethasone. Additionally, ketamine and magnesium sulphate gargles, as well as nebulization, have been tested, as these substances inhibit the N-methyl-D-aspartic acid receptor without providing direct analgesic effects. Research highlights the influence of factors like endotracheal tube size and cuff pressure on POST, yet literature on the effects of ketamine and magnesium sulphate aerosol is limited. This study aims to compare the impact of ketamine and magnesium sulphate atomizer spray on the occurrence of POST in adult patients undergoing general anaesthesia with endotracheal intubation. The study’s objective is to assess both the incidence of POST and the influence of these atomizer sprays on hemodynamic parameters.

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 60.00 Year(s)(—)
性别
All

入选标准

  • Age 18 years to 60 years
  • Elective surgeries
  • ASA classes 1,2, and 3.

排除标准

  • Patient refusal
  • Allergic to the study drugs
  • Anticipated difficult airway
  • Emergency surgeries
  • Head and neck surgeries.

结局指标

主要结局

To compare the effectiveness of magnesium and ketamine spray in reducing the incidence and severity of postoperative sore throat.

时间窗: five time intervals: 30-minute,1,6,12, and 24 hours after extubation.

次要结局

  • : To compare the effectiveness of magnesium and ketamine spray in reducing the incidence and severity of cough, dysphagia, and hoarseness(five time intervals: 30 minutes, 1,6, 12, and 24 hours after extubation.)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

JENIN HERBERT

Christian Medical College

研究点 (1)

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