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临床试验/CTRI/2025/09/095191
CTRI/2025/09/095191尚未招募2 期

A study on the comparison between preoperative nebulization with magnesium sulfate and ketamine in the prevention of postoperative sore throat during general anaesthesia with endotracheal intubation in adults

Department of Anaesthesia1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
70
试验地点
1
主要终点
To compare the incidence of postoperative sore throat (POST) in adult patients undergoing general anesthesia with endotracheal intubation between patients who received preoperative nebulization with ketamine 50mg and magnesium sulfate 500mg

研究概览

简要总结

A prospective randomized double blind study titled comparison between preoperative nebulization with magnesium sulphate and ketamine in the prevention of postoperative sore throat will be undertaken at ESIC Medical College a Hospital, Chennai. The study will be conducted on 70 patients belonging to ASA 1 and 2 undergoing elective surgery under general anaesthesia with endotracheal intubation. Study subjects will be divided into two study groups. Patients in Group A will be nebulized with Magnesium Sulphate 500mg, Group B with Ketamine 50mg . Nebulization will be  administered 20 minutes prior to the surgery. Postoperatively patients will be assessed for incidence and severity of POST, hoarseness of voice, and cough at intervals of 0, 2, 4, 6 and 24 hours using a 4 point scale. All continuous variables will be expressed in terms of descriptive statistics such as mean, standard deviation, range, standard error etc. Categorical data will be expressed in terms of frequency and percentage.

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 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients who have given written informed consent 2.ASA physical status 1 and 2.

排除标准

  • 1.Patients with known or anticipated difficult airway 2.Those who had undergone more than 3 attempts at intubation and those requiring airway adjuncts 3.Emergency surgeries 4.BMI more than 35 5.Pregnancy and lactation 6.History of preoperative sore throat or recent upper respiratory tract infection 7.History of oral surgeries, neck surgeries like thyroid surgery.

结局指标

主要结局

To compare the incidence of postoperative sore throat (POST) in adult patients undergoing general anesthesia with endotracheal intubation between patients who received preoperative nebulization with ketamine 50mg and magnesium sulfate 500mg

时间窗: Postoperatively at 0,2,4,6 and 24 hours

次要结局

  • 1)To assess the severity of POST (mild, moderate, or severe) in patients who received nebulized ketamine and nebulized magnesium sulfate(2)To evaluate the incidence of other complications in patients who received nebulized ketamine and magnesium sulfate, such as hoarseness of voice and cough)

研究者

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

Nivitha G

ESIC medical college and hospital, KK Nagar

研究点 (1)

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