A Comparative Analysis of Intranasal Midazolam and Intranasal Dexmedetomidine as Premedication in Pediatric Infraumbilical Surgeries: A Prospective Randomized Double-blind Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Preoperative Sedation Score
研究概览
简要总结
This study is a hospital-based, prospective, comparative, randomized, double-blind study to be conducted atDepartment of Anesthesia, Chacha Nehru Bal Chikitsalaya, New Delhi. The inclusion criteria are children aged 2-10 years undergoing elective infraumbilical surgeries of ASA grade I and II. 70 patients will be allocated in two groups, Group A (receiving intranasal midazolam 0.2 mg/kg) and Group B (intranasal dexmedetomidine 0.5 mcg/kg). The primary outcome measure is preoperative sedation score at the time of shifting into OT and the secondary outcome measure are parental separation score, mask acceptance score, preoperative and intraoperative vital parameters, postoperative emergence (Cravero score) and immediate postoperative sedation score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 2.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •Children undergoing infraumbilical surgeries
- •ASA grade I and II.
排除标准
- •Patients having known allergy to the drugs used in study
- •Patients having upper respiratory infection
- •Patients having neurological disorders
- •Patients under treatment with anticonvulsants/sedatives
- •Patients spitting out the medication.
结局指标
主要结局
Preoperative Sedation Score
时间窗: Prior to administration of study drugs and thereafter every 10 minutes till patients in shifted into operating room
次要结局
- Parental separation score(At the time of shifting into operating room)
- Mask acceptance score
- Preoperative and intraoperative vital parameters
- Postoperative emergence (Cravero score)(After completion of surgery and shifting into post anesthesia care unit)
- Immediate postoperative sedation score(After completion of surgery and shifting into post anesthesia care unit)