跳至主要内容
临床试验/CTRI/2026/03/105132
CTRI/2026/03/105132尚未招募4 期

A comparative study of intranasal dexmedetomidine and clonidine using a mucosal atomisation device on hemodynamic response t laryngoscopy during intubation

Anju Merine Sebastian1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2026年3月22日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
76
试验地点
1

研究概览

简要总结

This prospective, randomized, double-blind, two-arm parallel clinical trial aims to compare the efficacy and safety of intranasal dexmedetomidine and intranasal clonidine, administered via mucosal atomization device, in attenuating the hemodynamic response to laryngoscopy and endotracheal intubation in adult patients undergoing elective surgery under general anaesthesia. A total of 76 ASA I–II patients aged 18–60 years will be randomly allocated into two groups to receive either intranasal clonidine (3 mcg/kg) or intranasal dexmedetomidine (1 mcg/kg) 45 minutes prior to induction of anaesthesia. Hemodynamic parameters including heart rate and mean arterial pressure will be recorded at predefined intervals before and after intubation. Sedation will be assessed using Ramsay Sedation Score. The primary outcome is the change in mean arterial pressure at 1 minute after intubation compared to baseline. Secondary outcomes include heart rate changes, sedation profile, and incidence of adverse events. The study aims to determine the superior intranasal alpha-2 agonist for blunting the pressor response while maintaining hemodynamic stability and safety.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator 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

  • 18-60 years aged patients BMI 20-35 kg/m2 ASA I – II Availability of written informed consent Hemodynamically stable patients with all routine investigations within normal limits.

排除标准

  • 未提供

研究者

发起方
Anju Merine Sebastian
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Anju Merine Sebastian

Dr. D. Y. PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, PIMPRI, PUNE

研究点 (1)

Loading locations...

相似试验