跳至主要内容
临床试验/CTRI/2024/10/075734
CTRI/2024/10/075734尚未招募不适用

Comparison of Proseal Laryngeal Mask Airway with i-Gel in Elective Urological Surgeries - A Randomized clinical trial

ADHILAKSHMI R1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2024年11月1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
116
试验地点
1
主要终点
Hemodynamic Changes

研究概览

简要总结

This study proposal outlines a randomized controlled trial (RCT) aimed at comparing the Proseal Laryngeal Mask Airway (Proseal LMA) with the i-Gel in adult patients undergoing elective urological surgery. The primary objective is to assess and compare the efficacy, safety, and feasibility of these two airway management devices in terms of insertion success, airway sealing, and hemodynamic complications. The study will contribute to the evidence base, guiding anesthesiologists in choosing the most suitable airway device for elective surgical procedures.

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 65.00 Year(s)(—)
性别
All

入选标准

  • Adult patients aged 18-65 years.
  • Scheduled for elective urological (less than 4 hours) surgery under general anesthesia.
  • American Society of Anesthesiologists (ASA) physical status I or II.

排除标准

  • Patients requiring
  • Endotracheal intubation Emergency surgeries.
  • Known or anticipated difficult airway.
  • Prolonged surgical procedures for more than 4 hours
  • At risk of aspiration (pregnancy and gastro esophageal reflex disease).

结局指标

主要结局

Hemodynamic Changes

时间窗: At baseline, | At 1st Minute, | At 5th Minute

次要结局

  • Airway seal pressure (cmH2O).(Hemodynamic stability (heart rate, respiratory rate, spo2 and blood pressure).)

研究者

发起方
ADHILAKSHMI R
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Meera Rani Nayak

Dr. Kamakshi Memorial Hospital

研究点 (1)

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