临床试验/CTRI/2025/06/088010

CTRI/2025/06/088010尚未招募3 期

Intranasal dexmedetomedine for premedication in paediatric patients undergoing surgery under general anaesthesia

Gayatri Vidya Parishad Institute Of Health Care and Medical Technology1 个研究点分布在 1 个国家目标入组 60 人开始时间: 2025年7月14日最近更新: 2025年3月12日

试验速览

阶段: 3 期
状态: 尚未招募
发起方
入组人数: 60
试验地点: 1
主要终点: The sedative effects on the child in the pre operative period and while

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This interventional study is to compare the efficacy and safety of the

two different doses of intranasal dexmedetomidine 1mcg/kg and 1.5mcg/kg as a premedication in the

paediatric patients undergoing elective surgeries under general anaesthesia.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围: 1.00 Year(s) 至 12.00 Year(s)（—）
性别: All

入选标准

•Paediatric patients coming for elective surgery under general anaesthesia.
•Age between 1 to 12 years both sexes ASA 1 and ASA 2.

排除标准

•Parental refusal for consent ASA grade 3 and higher.
•Paediatric patients with cardiac problems.

结局指标

主要结局

The sedative effects on the child in the pre operative period and while

时间窗: 20mins

shifting to OT

时间窗: 20mins

次要结局

Pre op, Intra op, post op haemodynamics and saturation.(Behaviour and Wake up behavioural score.)

研究者

发起方

Gayatri Vidya Parishad Institute Of Health Care and Medical Technology

申办方类型

Private medical college

责任方

Principal Investigator

主要研究者

Dr Sarakam Sreelakshmi

Gayatri vidya parishad institute of health care and medical technology

研究点 (1)

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