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临床试验/CTRI/2025/07/091128
CTRI/2025/07/091128尚未招募4 期

A study comparing nebulised ketamine and midazolam as pre medicant in pediatric patient undergoing elective surgery

Pt BD Sharma PGIMS Rohtak1 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30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
60
试验地点
1
主要终点
Comparison of level of sedation and effectiveness of nebulised ketamine and midazolam as premedicant

研究概览

简要总结

The present prospective study will be conducted in the department of anesthesia and critical care, PGIMS Rohtak. Written informed consent will be taken from patients included. Then comparison of effectiveness of nebulised ketamine and midazolam as pre medicants. Data will be compiled and analysed with appropriate statistical test.

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
2.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • ASA grade I & II scheduled to undergo various elective surgical procedures.

排除标准

  • children with history of developmental delay
  • children with systemic illness like.
  • cardiac diseases, neurological, liver and renal disease. 3.parents refusing to give consent.
  • known allergy or hypersensitivity to ketamine or midazolam.

结局指标

主要结局

Comparison of level of sedation and effectiveness of nebulised ketamine and midazolam as premedicant

时间窗: From the time of administration of drug at every 5 mins interval for first 30 mins

次要结局

  • To compare time of onset of action, ease of child-parent separation, ease of induction in operative room, and effect of two drugs on intra-operative hemodynamics(From the time of administration of drug at every 5 mins interval for first 30 mins)

研究者

发起方
Pt BD Sharma PGIMS Rohtak
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Sanjay Johar

Pt BD Sharma PGIMS Rohtak

研究点 (1)

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