To Compare Dexmedetomidine and Midazolam for Intra-op Sedation in TIVA in Children Undergoing Inguinal Hernia Repair
试验速览
- 阶段
- 1 期
- 入组人数
- 185
- 主要终点
- Level of sedation assessed through Ramsay Sedation Scale RSS
研究概览
简要总结
To compare dexmedetomidine and midazolam for intra-op sedation in TIVA in children undergoing inguinal hernia repair. The results of the study if found significant will guide the anesthetist in appropriate choice and dose of sedative drug with highest efficacy and minimum side effects to avoid post operative adverse effects associated with anesthesia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 12 Months 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female paediatric patients In age range neonates to 15 years
- •Planned for elective inguinal hernia repair
- •Patients with uncomplicated hernia With ASA class I or II
排除标准
- •Patients undergoing emergency inguinal repair
- •Patients with ASA class III,IV,V or VI
- •Patients present with complicated hernia
- •Patients with BMI above 40kg/m2
- •Patients with any allergy to anesthesia
- •Patients with coagulopathy
- •Patients with narcotic/opioid addiction
研究组 & 干预措施
Dexmedetomidine
Inj. Dexmedetomidine (precidex) 200/mcg/2ml given to participants in infusion form for 10 mins of surgery and maintenance dose given till the end of surgery
干预措施: Dexmedetomidine (Drug)
Midazolam
Inj midazolam 0.5 mg/kg stat dose will be given to participants during surgery
干预措施: Midazolam (Drug)
结局指标
主要结局
Level of sedation assessed through Ramsay Sedation Scale RSS
时间窗: 6 months
次要结局
未报告次要终点
研究者
Anab Farooqi
Dr. Anab Farooqi
Sheikh Zayed Medical College