跳至主要内容
临床试验/CTRI/2025/03/081994
CTRI/2025/03/081994尚未招募不适用

Effect of intratracheal Dexmedetomidine to attenuate cardiovascular and airway responses to tracheal extubation.

Christian Medical college and hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年3月22日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
90
试验地点
1
主要终点
After instillation of dexmedetomidine intratracheal following parameters will be measured

研究概览

简要总结

Introduction: Peri-Extubation cough is an unpleasant event, prevention of which has been studied with multiple

pharmacological strategies among which intravenous Dexmedetomidine has emerged as one of the preferred drug.

Intratracheal route is attractive as it is easy to use and moreover it avoids hypotension and bradycardia associated

with intravenous drug administration. But, there is lack of data exploring the efficacy, dosage and adverse effects

of intratracheal Dexmedetomidine.

Aims and Objectives :

1.To assess the effectiveness of intratracheal Dexmedetomidine in different doses to attenuate the cardiovascular

and airway responses to tracheal extubation.

2.To observe the adverse effects of Dexmedetomidine.

Materials and Methods:

This study will be conducted on 90 Patients with ASA I and II status scheduled for surgery under general

anaesthesia. They will be randomly divided into three groups – Group D1, Group D2, and Group N. 30 minutes

prior to extubation these groups will receive intratracheal dexmedetomidine 0.3mic/kg, 0.5mic/kg and 2ml NS

respectively. Hemodynamics responses, time taken for extubation, quality of extubation and time to achieve the

Ramsay sedation score of 3 will be recorded.

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 65.00 Year(s)(—)
性别
All

入选标准

  • Patients aged 18-65 years Patients of ASA grade 1 and 2 Either sex Patients scheduled for general anaesthesia.

排除标准

  • Patients with recent upper respiratory tract infections Patients with uncontrolled or untreated hypothyroidism Patients with heart disorders like heart block, coronary heart disease Hepatic and renal insufficiency Patients on alpha 2 agonist and sedative drugs.

结局指标

主要结局

After instillation of dexmedetomidine intratracheal following parameters will be measured

时间窗: At the time of instillation of dexmedetomidine , After drug intillation @ 5 min, 10 min, 20 min, 30 min

• Haemodynamic parameters- Heart rate,Blood pressure, SpO2,

时间窗: At the time of instillation of dexmedetomidine , After drug intillation @ 5 min, 10 min, 20 min, 30 min

•Adverse effects- Hypotension , breath holding, Bradycardia, emergence delirium

时间窗: At the time of instillation of dexmedetomidine , After drug intillation @ 5 min, 10 min, 20 min, 30 min

次要结局

  • After extubation following parameters will be measured(• Haemodynamic parameters- Heart rate,Blood pressure, SpO2,)
  • 1. Ramsay sedation score at the time of extubation :(2. Time to reach ramsay sedation score of 3:)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Hemani Ahuja

Christian Medical college and hospital,brown road, ludhiana

研究点 (1)

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