跳至主要内容
临床试验/CTRI/2025/11/097919
CTRI/2025/11/097919尚未招募不适用

Comparison of effect of two different Dexmedetomidine infusion rates on emergence agitation in paediatric surgical patients receiving general anaesthesia with volatile anaesthetic agents

Department of Anaesthesiology1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年12月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
The study aims to provide evidence on whether a lower infusion rate (0.2 mcg/kg/hr) is as effective as a slightly higher rate (0.3 mcg/kg/hr) in preventing EA, while minimizing hemodynamic instability. The results could guide pediatric anesthesia practice by optimizing dexmedetomidine dosing protocols, improving patient safety, enhancing recovery profiles and reducing perioperative complications related to EA.

研究概览

简要总结

This prospective randomized study aims to compare two dexmedetomidine infusion rates 0.2 and 0.3 micrograms per kilogram per hour for preventing emergence agitation in children aged two to twelve years undergoing general anesthesia One hundred patients will be divided into two equal groups and given standardized anesthesia using volatile agents Emergence agitation and pain will be assessed using clinical scales in the postoperative period The study will compare the incidence severity recovery time and adverse effects including bradycardia hypotension and desaturation to identify the optimal infusion rate that ensures effective prevention of emergence agitation with stable hemodynamic parameters

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
2.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • (i) Age group 2 to 12 years (ii) Both male and female patients (iii) ASA grade I to II (iv) Undergoing elective surgery in GA.

排除标准

  • (i) Patients or Parents refusal to consent for the study (ii) Patient with Respiratory and cardiac Diseases (iii) Delayed Milestones (iv) Patient with psychiatric disease (v) ASA Grade III and above (vi) Emergency surgery under GA.

结局指标

主要结局

The study aims to provide evidence on whether a lower infusion rate (0.2 mcg/kg/hr) is as effective as a slightly higher rate (0.3 mcg/kg/hr) in preventing EA, while minimizing hemodynamic instability. The results could guide pediatric anesthesia practice by optimizing dexmedetomidine dosing protocols, improving patient safety, enhancing recovery profiles and reducing perioperative complications related to EA.

时间窗: Interim Assessments after every 06 months

次要结局

  • 1.Comparison of duration of recovery in each group(2. Adverse events in each group)

研究者

发起方
Department of Anaesthesiology
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Harindra Kumar Goje

INHS ASVINI

研究点 (1)

Loading locations...

相似试验