A Study Comparing Nebulised Dexmedetomidine vs midazolam as premedicant in pediatric patient undergoing elective surgery
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
Dr Yashika Yadav
Jawaharlal Nehru Medical College and hospital
