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临床试验/CTRI/2025/11/097139
CTRI/2025/11/097139尚未招募Phase 3 4

A clinical study comparing effectiveness of intranasal versus intravenous dexmedetomidine for attenuation of hemodynamic responses of laryngoscopy and endotracheal intubation n patients undergoing general anaesthesia.

Chatrapati Shivaji Subharti Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
Heart Rate

研究概览

简要总结

There are many literature regarding  intravenous dexmedetomidine in attenuating the response to laryngoscopy and intubation but there is a lack of enough literature regarding intranasal use of dexmedetomidine for attenuation of response to laryngoscopy and intubation. Intranasal route is helpful preferred as it avoids needle anxiety and semi invasive.

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

  • ASA (American Society of Anesthesiologists) grade 1 and 2.

排除标准

  • Patient refused to participate Patient with known allergy and hypersensitivity to study drug.

结局指标

主要结局

Heart Rate

时间窗: Baseline,10 minute, 20 minute, 30 minute, 40 minute, At Induction, At laryngoscope and Intubation, 1minute, 2 minute, 3minute, 4 minute, 7 minute, 10 minute.

Systolic Blood Pressure

时间窗: Baseline,10 minute, 20 minute, 30 minute, 40 minute, At Induction, At laryngoscope and Intubation, 1minute, 2 minute, 3minute, 4 minute, 7 minute, 10 minute.

Diastolic Blood Pressure

时间窗: Baseline,10 minute, 20 minute, 30 minute, 40 minute, At Induction, At laryngoscope and Intubation, 1minute, 2 minute, 3minute, 4 minute, 7 minute, 10 minute.

MAP (Mean arterial pressure)

时间窗: Baseline,10 minute, 20 minute, 30 minute, 40 minute, At Induction, At laryngoscope and Intubation, 1minute, 2 minute, 3minute, 4 minute, 7 minute, 10 minute.

次要结局

  • Post-operative sedation(Ramsay sedation score)(Baseline, At Intubation, 1 Hour, 2 Hour, 4 Hour, 6 Hour.)

研究者

发起方
Chatrapati Shivaji Subharti Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

PAVANKUMAR S HANDRAL

Subharti Medical College

研究点 (1)

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