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临床试验/CTRI/2022/07/044460
CTRI/2022/07/044460尚未招募不适用

A randomized double-blind controlled study of attenuation of hemodynamic responses to laryngoscopy and intubation after intranasal administration of dexmedetomidine

Kidwai memorial institute of oncology1 个研究点 分布在 1 个国家目标入组 166 人开始时间: 2022年7月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
166
试验地点
1
主要终点
Hemodynamic responses to laryngoscopy and intubation

研究概览

简要总结

Dexmedetomidine  is a highly selective short acting alpha 2 agonist. It can provide sedative, analgesic, anxioytic effects with minimal respiratory depression. Several studies also suggest efficacy in blunting hemodynamic  responses to laryngoscopy and intubation.  Since intravenous  use has been associated with several cases of sudden cardiac arrest and delayed post operative  recovery, we use intranasal route for our study which also is said to have good patient acceptance.  We intend to study the attenuation of hemodynamic responses to laryngoscopy and intubation following preoperative intranasal administration  of dexmedetomidine  45 minutes prior to laryngoscopy and intubation when given at a dose of 0.5 micrograms per kg. Additionally we also intend to study preoperative  anxiolysis and sedative properties of dexmedetomidine  when given intranasal. This shall be compared against intranasal administration of saline 45 minutes prior to laryngoscopy  and intubation.  The study shall be done in a randomized  double blinded placebo controlled manner. Statistical  tests  for significance shall be performed  after obtaining  the data.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
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 between 18 to 65 years belonging to ASA status 1 ad 2 with BMI between 18 -25 kgm2 undergoing surgery under general anesthesia.

排除标准

  • Patient refusal.
  • Patient with known nasal pathology.
  • History of allergy to study drug or other anesthetic agents.patient with history ischemic heart disease, cerebrovascular accident, or cardiovascular disease.
  • Patient with second or third degree heart blocks.
  • Patients on long term sedatives or anxiolytics.
  • Patients on Anti hypertensive like clonidine, beta blockers, alpha methyl dopa, alpha adrenergic agonists.

结局指标

主要结局

Hemodynamic responses to laryngoscopy and intubation

时间窗: 60 minutes

次要结局

  • Sedation, anxioysis(45 minutes)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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