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临床试验/CTRI/2025/10/096417
CTRI/2025/10/096417尚未招募Unknown

Laryngeal Mask Airway Supreme vs I gel A Comparison Of First Attempt Success Rate Among Novices

SRM Medical College Hospital1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2025年11月2日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
88
试验地点
1
主要终点
To compare the first attempt success rate among novices between LMA supreme and I-gel in patients undergoing elective procedures under general anesthesia

研究概览

简要总结

The study will be conducted post approval from IEC and CTRI.

Patients will be hospitalised the day before surgery and instructed to fast for 6 hours (for solids) and 4 hours (for liquids) prior to the procedure.

Inj Pantaprazole 40mg IV and Inj Metaclopramide 10mg IV will be administered 30 minutes prior to surgery.

In the OT, infusion of ringer lactate will be started. Patients will be connected to a multichannel monitor displaying electrocardiography, oxygen saturation, non invasive blood pressure and end tidal carbon dioxide. Leak pressure will also be monitored.

All the patients will be administered Inj Glycopyrrolate 0.2mg IV, Inj Midazolam 1mg IV, Inj Fentanyl 2mcg/kg IV. Preoxygenation will be done for 3 minutes. All the patients will be induced with Inj Propofol 2mg/kg IV in slow incremental dose and ease of mask ventilation will be noted.

Selection of the size of LMA supreme and I-gel will be on the bases of the weight of the patient. The SAD’s will be inserted as per manufacturer’s user booklet. Adequate ventilation will be confirmed by chest movements and EtCO2 waveforms. Time of insertion will be defined from the removal of face mask to the time where adequate ventilation was established through SAD with capnographic confirmation. Complications including airway injury, laryngospasm and sore throat will be noted.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

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 assessed under ASA 1 ASA2 Patients undergoing surgery under general anesthesia Weight of patients between 30kg to 100kg.

排除标准

  • Patients who refuse to participate in the study Known or anticipated difficult airway(RODS criteria) Surgery prolonging more than 45 minutes Full stomach patients.

结局指标

主要结局

To compare the first attempt success rate among novices between LMA supreme and I-gel in patients undergoing elective procedures under general anesthesia

时间窗: To compare the first attempt success rate among novices between LMA supreme and I-gel in patients undergoing elective procedures under general anesthesia during induction

次要结局

  • To compare insertion time, overall success rate(intraoperative period)
  • To compare oropharyngeal leak pressure(Immediately post insertion)
  • To compare ease of ryles tube insertion and airway complications(During placement and within two hours postoperatively)

研究者

发起方
SRM Medical College Hospital
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Venkata Padmavathi G

Srm Medical College Hospital And Research Institute

研究点 (1)

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