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临床试验/CTRI/2025/04/084494
CTRI/2025/04/084494尚未招募3 期

Effect of exchange extubation using I-gel over traditional awake extubation on vital parameters and quality of extubation .

Gandhi Medical College Bhopal1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2025年4月28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
75
试验地点
1
主要终点
Hemodynamic parameters

研究概览

简要总结

The approval of the hospital ethics and scientific committee will be obtained and the written and informed consent of the patient will be taken. All the patients will be kept NBM for 6 hours preoperatively. Airway examination of the patients according to standard protocol will be done.On arrival in the operation theatre, routine monitoring will be done and baseline. General anaesthesia with endotracheal intubation will be given as per standard protocol.In group 1, at the end of surgical procedure, vital parameters will be noted, ETT extubation will be Done. In group 2, at the end of surgical procedure, vital Parameters will be recorded, oropharynx will be suctioned. Then ETT will be removed under the laryngoscopy in deep anaesthesia and I-gel will be placed. I- gel will be connected to breathing circuit. I-gel extubation is done.

Vital parameters will be recorded for both groups after 5minutes, 10minutes and 15minutes of extubation. Respiratory parameters such as bucking, coughing and Sore throat will be observed for both groups till 15 minutes after extubation

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Double

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • ASA Grade I and II Elective surgery under general anaesthesia.

排除标准

  • Emergency surgery Contraindications for I-gel insertion Obese patients Difficult airway patients Oral cavity/throat surgery.

结局指标

主要结局

Hemodynamic parameters

时间窗: Vitals are to be monitored after end of surgery,after exchange , 5/10/15 minutes after extubation /removal of i-gel

次要结局

  • 1.Respiratory parameters(2.Time interval between end of surgery and extubation of endotracheal tube/ i-gel)

研究者

发起方
Gandhi Medical College Bhopal
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Aishwaray Gadhawe

Gandhi Medical College BHOPAL

研究点 (1)

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