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临床试验/CTRI/2025/11/097868
CTRI/2025/11/097868尚未招募不适用

A Comparative Study on Efficacy of Dexmedetomidine, Fentanyl and Midazolam on Post Intubation Sedation in Trauma Patients

Vinayaka Missions Kirupananda Variyar Medical College and Hospitals1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2025年12月3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
105
试验地点
1

研究概览

简要总结

This prospective observational study compares the sedation efficacy and hemodynamic effects of Dexmedetomidine, Fentanyl, and Midazolam in trauma patients who require emergency intubation and mechanical ventilation. Adult patients meeting the inclusion/exclusion criteria presenting to the Emergency Department and those patients needing intubation and whom sedatives were administered as per Physicians order as part of routine clinical care will be observed and allocated into three groups . Sedation depth, hemodynamic parameters, respiratory variables, and additional sedative requirements are recorded at predefined intervals (Baseline, 30 minutes, 4 hours, 12 hours, 36 hours, and 48 hours). The study aims to determine which agent provides optimal sedation with better hemodynamic stability and fewer adverse effects. Findings are expected to support evidence-based emergency department sedation protocols for intubated trauma patients.The expected outcome will show Dexmedetomidine is a better agent compared to Fentanyl and Midazolam for sedation in mechanically ventilated traumatic patients. Dexmedetomidine also reduced the additional sedation requirement

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • All trauma patients presenting to the Department of Emergency Medicine VMKV MCH during the study period who are intubated in the Emergency Department with age 18-70yrs with American Society of Anaesthesiologists grade I and II.

排除标准

  • Exclusion criteria included significant hepatic and renal impairment, hypotension, bradycardia, and a known allergy to any of the study drug.
  • Patient, for whom consent was not given, lost in follow up during the study period, who died during the study period, and American Society of Anaesthesiologists (ASA) grade more than III are also excluded.

研究者

发起方
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr. M. Senthil Kumar

Vinayaka Missions Kirupananda Variyar Medical College and Hospitals

研究点 (1)

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