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临床试验/CTRI/2024/09/074162
CTRI/2024/09/074162尚未招募3 期

A study to compare the effects on laryngotracheal morbidity of air, 2 percent alkalinized lignocaine and dexamethasone used for endotracheal tube cuff inflation, a randomized control trial.

Institute of Postgraduate Medical Educationand Research1 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2024年10月2日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
165
试验地点
1
主要终点
sore throat incidence/severity

研究概览

简要总结

Endotracheal intubation often causes several postoperative laryngotracheal morbidities like sore throat, cough, dysphagia, hoarseness of voice. Different medications and techniques have been adopted to relieve these complications. Injecting alkalinized lignocaine into endotracheal tube cuff has already shown promising results in various studies. Injection Ketamine used intracuff also gave comparable results, but studies on intracuff dexamethasone are very few. Dexamethasone is a potent corticosteroid with analgesic, anti-inflammatory, and antiemetic properties. Preoperative IV dexamethasone has been reported to reduce the incidence of postoperative pain and swelling following oral surgeries. Even when used intracuff, dexamethasone yielded favorable results in the few studies that we have come across. Therefore, we wish study the effects of injection Dexamethasone against 2% alkalinized Lignocaine when used as an intracuff reservoir in relieving laryngotracheal morbidities.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant 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 to 60 years, ASA 1 and 2 undergoing elective surgery under general anaesthesia, patient given written informed consent.

排除标准

  • Duration of surgery 2 to 4 hrs, difficult airway requiring more than 2 trials of intubation, history of sore throat, allergies, bronchial asthma, chronic obstructive pulmonary disease, upper respiratory tract infections.

结局指标

主要结局

sore throat incidence/severity

时间窗: 1 hr,12 hr,24 hr post extubation

次要结局

  • hoarseness of voice(1 hr,12 hr,24 hr post extubation)
  • PONV(1 hr,12 hr,24 hr post extubation)
  • cough(1 hr,12 hr,24 hr post extubation)
  • dysphagia(1 hr,12 hr,24 hr post extubation)

研究者

发起方
Institute of Postgraduate Medical Educationand Research
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Subhrajyoti Das

Institute of Postgraduate Medical Education and Research

研究点 (1)

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