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临床试验/CTRI/2025/07/091540
CTRI/2025/07/091540尚未招募不适用

Effects Of Dexmedetomidine And Fentanyl On Insertion Of i-Gel In Patients Undergoing Surgery Under General Anaesthesia- A Randomized Clinical Trial.

A SUDARSHAN1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年8月4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
80
试验地点
1
主要终点
Objective of this study to assess the effects of dexmedetomidine and fentanyl on the ease of insertion and hemodynamic changes on placement of i-gel

研究概览

简要总结

General anaesthesia is a critical component of many surgical procedures, ensuring patient comfort and optimal conditions for surgeons. Among the various tools and drugs used in general anaesthesia, i-gel, a second generation supraglottic airway not only has an easier insertion but has also been reported to cause lesser airway morbidity. This will be a randomized clinical trial conducting to compare the effects of i-gel insertion conditions using dexmedetomidine and fentanyl in patients undergoing surgery under general anaesthesia.

A total of 80 patients, ASA i/ii, aged 18-60 years undergoing general anaesthesia for elective surgical procedures, fulfilling the inclusion criteria and willing to give informed written consent will be enrolled. They will be randomly allocated into two groups. Group A (patients will receive 0.5mcg/kg dexmedetomidine) and Group B (patients will receive 1mcg/kg fentanyl). I-gel insertion conditions with both the groups will be assessed and compared. Hemodynamic changes during i-gel insertion using both the groups will be determined and compared.

The data will be analysed using SPSS statistics software version 26. Student t-test will be used for comparisons between HR and MAP at each time point and Chi-square test will be used for categorical data.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator 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

  • Patients aged between 18-60 years
  • American Society of Anaesthesiologists Physical Status 1 & 2
  • Patients undergoing general anaesthesia for elective surgical procedures.

排除标准

  • 1.Patients not willing to participate in the study
  • Patients with reduced mouth opening
  • Neck and Facial burns and contracures
  • Body Mass Index more than 30
  • Upper and Lower airway obstruction
  • Patients on beta blockers
  • Patients with known allergy to study drugs.

结局指标

主要结局

Objective of this study to assess the effects of dexmedetomidine and fentanyl on the ease of insertion and hemodynamic changes on placement of i-gel

时间窗: Objective of this study to assess the effects of dexmedetomidine and fentanyl on the ease of insertion on placement of i-gel and hemodynamic changes on placement of i-gel after 1minute and 3minutes and 5minutes and 10minutes after the placement of i-gel

次要结局

未报告次要终点

研究者

发起方
A SUDARSHAN
申办方类型
Other [POST GRADUATE TRAINEE]
责任方
Principal Investigator
主要研究者

A SUDARSHAN

REGIONAL INSTITUTE OF MEDICAL SCIENCES

研究点 (1)

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