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临床试验/CTRI/2025/04/084713
CTRI/2025/04/084713尚未招募不适用

A Study Comparing Nebulised Dexmedetomidine vs midazolam as premedicant in pediatric patient undergoing elective surgery

Jawaharlal Nehru Medical College and hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年4月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
90
试验地点
1
主要终点
assessment of sedation score

研究概览

简要总结

This will be a double blinded randomised study conducted to evaluate efficacy of nebulised dexmedetomidine 2micogram/kg and nebulised midazolam0.2mg/kg, study drugs will be diluted in 3ml of 0.9% normal saline  as premedication in children aged between 3-10 years undergoing surgery under general anesthesia ,administred 30 mins before the induction of general anesthesia via jet nebuliser , in ASA 1 or 2 patients with exemption of all exclusion criteria mentioned above with primary objective of comparing the efficacy of nebulised dexmedetomidine and nebulised midazolam as sedative premedication . Secondary objectives being comparing the premedicants in terms of achieving ,alleviating parent separation anxiety, providing better face mask acceptance, least emergence reactions. Group D receiving nebulised dexmedetomidine and group M receving nebulised midazolam in above mentioned doses. preanesthetic  evaluation will be done previous day, informed written consent will be taken prior to surgery , all emergency drugs and equipments will be kept ready in prior. patient will be monitored preoperative, intraoperative and postoperatively. the parameters will be recorded at predescribed intervals and documented . data will be analysed statistically using  standard qualitative and quantitative tests , continous variables will be analysed using student paired test and categorical variables will be analysed using chi square test . P value less than 0.05 will be considred significant.

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
3.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • 1 patients belonging to ASA physical status 1 and 2 2 patients aged 3-10years 3 patients posted for elective surgical procedures under general anesthesia.

排除标准

  • 1 parent refusal 2 emergency 3 children with known allergy to study drugs 4 significant organ dysfunction 5 congenital disorders 6 behavioural disorders 7 children with more than 85th percentile of body mass index for age percentiles.

结局指标

主要结局

assessment of sedation score

时间窗: Baseline

次要结局

  • parental separation score(at 5min, 10min, 20min, 30min)
  • mask acceptance score(at 5min, 10min, 20min, 30min)
  • assessment of recovery
  • assessment of emergence agitation

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Yashika Yadav

Jawaharlal Nehru Medical College and hospital

研究点 (1)

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