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临床试验/CTRI/2025/12/099094
CTRI/2025/12/099094尚未招募不适用

A comparative study of endotracheal cuff inflation with 2 percentage alkalinised lignocaine vs air for preventing Post-Operative Sore Throat (POST) and reducing emergence phenomena after tracheal extubation in adult patients undergoing general anaesthesia

Self myself2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年12月25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
50
试验地点
2
主要终点
HR,BP,MAP, Post op sore throat, post op nausea and vomiting

研究概览

简要总结

All patients will undergo preoperative evaluation and receive standardized premedication. General anaesthesia will be induced with propofol and vecuronium, followed by tracheal intubation using a cuffed endotracheal tube. Depending on group allocation, the cuff will be inflated either with alkalinised 2% lignocaine or with air. Anaesthesia will be maintained with oxygen, air, and sevoflurane under controlled ventilation. Standard monitoring and intraoperative cuff pressure measurements will be performed throughout surgery. At the end, neuromuscular blockade will be reversed, and extubation carried out after suctioning. Postoperatively, patients will be monitored for hemodynamic changes, cough, sore throat, and nausea or vomiting for 12 hours.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • All adult patients undergoing elective surgery under general anaesthesia requiring cuffed endotracheal tube ASA1 ASA2 ASA3.

排除标准

  • Allergy to local anaesthetics Those who are not willing for study Terminally ill patients Paediatric population.

结局指标

主要结局

HR,BP,MAP, Post op sore throat, post op nausea and vomiting

时间窗: 1.Heart rate, BP, MAP will be recorded prior to extubation, immediately following extubation, and after the patient is shifted to the postoperative ICU. | 2.Just after extubation, patients will be assessed for the incidence of cough postoperatively using the Minogue Cough Score and reassessed again at 1 hr, 6 hr, and 12 hr post-extubation of trachea. | Will be assessed for postoperative sore throat (POST) using a sore throat score at 1 hr, 6 hrs, and 12hr

次要结局

  • To compare the incidence of postoperative cough following inflation of the(endotracheal tube cuff with 2% alkalinised lidocaine versus air)
  • To assess postoperative emergence by comparing hemodynamic changes,(including heart rate, blood pressure, & mean arterial pressure, after)
  • To compare the incidence of postoperative nausea & vomiting between(patients whose endotracheal tube cuffs are inflated with 2% alkalinised)
  • To assess patient satisfaction 12 hours after surgery under general(anaesthesia, comparing patients whose endotracheal tube cuffs were)

研究者

发起方
Self myself
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Diya Jolly

Sree Uthradom Thirunal Academy of Medical Sciences, Thiruvananthapuram

研究点 (2)

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