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临床试验/CTRI/2019/01/017060
CTRI/2019/01/017060已完成不适用

The effect of preoperative dexmedetomidine nebulization on hemodynamic response to laryngoscopy and intubation:placebo controlled randomized trial

Dr Satyajeet Misra1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年1月15日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
Changes in heart rate and blood pressure between the two groups

研究概览

简要总结

Laryngoscopy and intubation cause increase in heart rate and blood pressure which may be harmful in patients with coronary artery, cerebrovascular or intracranial disease. Various drugs like opioids, beta blockers and calcium channel blockers, local anaesthetic agents and alpha-2 receptor agonists have been tried to obtund this response with varying degrees of success. Dexmedetomidine, an alpha-2 receptor agonist, when tried by the intravenous route is effective in minimizing this response but causes hypotension and bradycardia. Nebulized route will have the advantage of minimal systemic effects. Thus, it would be of value addition to study whether the inhaled route of administration of dexmedetomidine is effective in minimizing the hemodynamic effects of laryngoscopy and intubation without causing the systemic side effects of hypotension and bradycardia. Till date, no trial has ever studied the effect of nebulized dexmedetomidine on the hemodynamic response to laryngoscopy and intubation.

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 60.00 Year(s)(—)
性别
All

入选标准

  • Adult patients posted for elective surgery will be recruited into the trial after obtaining their written informed consent.
  • The dexmedetomidine group will receive nebulization with 1 microgram/kg dexmedetomidine diluted in 3-4 ml normal saline 30 minutes before induction of anaesthesia.
  • Heart rate and blood pressure responses to laryngoscopy and intubation will be recorded for 10 minutes after laryngoscopy.
  • The normal saline group (control) will receive nebulization with normal saline (3-4 ml) 30 minutes before induction of anaesthesia and heart rate and blood pressure responses to laryngoscopy and intubation will be recorded for 10 minutes after laryngoscopy.

排除标准

  • Patients who undergo emergency surgeries, have known or unanticipated difficult airway and those who are on anti-hypertensive medications will be excluded from the trial.

结局指标

主要结局

Changes in heart rate and blood pressure between the two groups

时间窗: Upto 10 minutes following laryngoscopy

次要结局

  • Postoperative nausea and vomiting and sore throat(First 2 hours following surgery)

研究者

发起方
Dr Satyajeet Misra
申办方类型
Other [Additional Professor, Dept of Anaesthesia, AIIMS Bhubaneswar]

研究点 (1)

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