跳至主要内容
临床试验/CTRI/2025/09/094514
CTRI/2025/09/094514尚未招募2 期

comparison of hemodynamic profile during insertion of I gel using ketamine propofol and dexmedetomidine propofol in short general anaesthesia procedure A randamized controlled study

S jayasri1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2025年9月29日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
78
试验地点
1
主要终点
Hemodynamic parameters and

研究概览

简要总结

Supraglottic airway devices like the i-gel are increasingly used during short general anaesthesia procedures due to their ease of insertion and reduced hemodynamic disturbance compared to traditional intubation. Propofol, a commonly used induction agent, requires higher doses for effective i-gel placement, potentially leading to hypotension and respiratory depression. To counter this, co-induction with either ketamine or dexmedetomidine has been explored. This study aims to compare the effectiveness and safety of ketamine-propofol versus dexmedetomidine-propofol combinations, focusing on hemodynamic changes, ease of insertion, and recovery profiles.

The study is a prospective, randomized, single-blinded clinical trial involving 78 adult patients undergoing elective short surgical procedures. Patients were divided into two groups: Group A received ketamine (1 mg/kg) with propofol (1.5 mg/kg), and Group B received dexmedetomidine (1 µg/kg over 10 minutes) with propofol (1.5 mg/kg). Standard premedication was administered, and insertion of the i-gel was performed following a negative trapezius squeeze test. Variables assessed included jaw relaxation, insertion conditions, hemodynamic parameters, time taken for insertion, number of attempts, need for additional propofol, and Aldrete recovery scores.

The primary outcomes focus on comparing heart rate, blood pressure, and oxygen saturation between the two groups, while secondary outcomes include insertion ease, propofol requirement, adverse events, and post-operative recovery scores. The study is expected to clarify which co-induction combination better maintains hemodynamic stability and facilitates smoother i-gel insertion. The findings could guide anaesthetic practices in selecting the optimal sedative combination for safer and more efficient airway management in short-duration surgeries.

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

  • patient undergoing short elective surgical procedure patient of ASA physical status I and II.

排除标准

  • Anticipated difficult airway History of hypersensitivity to any study drug psychiatric disorders.

结局指标

主要结局

Hemodynamic parameters and

时间窗: Hemodynamic parameters base line 1 min,3 min,5 min,10 mins after insertion

ease of supra glottic airway device

时间窗: Hemodynamic parameters base line 1 min,3 min,5 min,10 mins after insertion

次要结局

  • Aldrete score(1 min and 10 min after procedure done)

研究者

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

s jayasri

Sri manakula vinayagar Medical College and Hospital Kalitheerthalkuppam,Puducherry 605107

研究点 (1)

Loading locations...

相似试验