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临床试验/CTRI/2023/06/053612
CTRI/2023/06/053612尚未招募不适用

COMPARISON OF EFFECT OF PRE – OPERATIVENEBULIZATION WITH DEXAMETHASONE, MAGNESIUMSULPHATE AND KETAMINE ON THE INCIDENCE OF POSTOPERATIVE SORE – THROAT AFTER ENDOTRACHEALINTUBATION IN PATIENTS UNDERGOING LAPAROSCOPICCHOLECYSTECTOMY: A RANDOMIZED DOUBLE BLIND STUDY.

FORTIS HOSPITAL, MOHALI1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2023年6月20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
140
试验地点
1
主要终点
To assess the incidence and severity of post operative sore throat.

研究概览

简要总结

Post operative sore throat (POST) is one of the most common complication in general anaesthesia along with hoarseness of voice and cough. These all maybe considered as a minor complication after surgery and anaesthesia that resolve after few days but it causes discomfort to the patient and decreases the quality of recovery and patient satisfaction. Although symptoms subside without any treatment, the management for POST is still advised. Various pharmacological agents have been used to prevent POST including both intravenous, topical and nebulized drugs. Intravenous agents include steroids, ketamine, magnesium sulphate and lignocaine. Drugs like magnesium sulphate, ketamine, dexamethasone, lignocaine have been used as gargles, topical application on endotracheal tube or nebulization with varying efficacies.

Nebulization is considered better than gargles as it is an easier way to administer the drug, requires a small volume of drug, pungent taste of gargled medication is avoided and is safer method of drug delivery.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Double Blind Double Dummy

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients between 18 to 65 years of either sex undergoing surgery in general anaesthesia in supine position.
  • Duration of surgery upto 2 hours.
  • ASA Grade I and II.

排除标准

  • ASA Grade III and IV.
  • History of recent upper airway infection.
  • Anticipated difficult airway.

结局指标

主要结局

To assess the incidence and severity of post operative sore throat.

时间窗: 0, 1, 4 and 24 hours.

次要结局

  • To assess the incidence and severity of post operative hoarseness of voice and cough, hemodynamic parameters and side effects if any.(0, 1, 4 and 24 hours.)

研究者

发起方
FORTIS HOSPITAL, MOHALI
申办方类型
Research institution and hospital

研究点 (1)

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