To compare the different doses of dexmedetomidine for caudal anaesthesia in paediatric patients
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- duration of postoperative analgesia
研究概览
简要总结
Dexmedetomidine in comparison to other sedatives has minimal respiratory effects in adults and children which make it a good adjuvant. Sedation caused by dexmedetomidine can be easily reversed with slight stimulation and does not cause respiratory depression even at high doses.
Commonly used dose of dexmedetomidine in caudal anaesthesia are 1 μg kg−1 to 2 μg kg−1. We hypothesized that adding lower doses of dexmedetomidine to caudal bupivacaine would achieve effective analgesia for sufficient duration with less risk of complications in comparison to higher doses in children.
The rationale of conducting the study is comparing the efficacy of different doses of dexmedetomidine with 0.25% bupivacaine in pediatric patients is to improve postoperative analgesia while maintaining hemodynamic stability in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 6.00 Month(s) 至 5.00 Year(s)（—）
- 性别
- All
入选标准
- •American Society of Anaesthesiologists Physical Status I and II
- •Children where single shot caudal epidural is planned for post operative analgesia will be included in the study.
排除标准
- •Local infection in the caudal region
- •Preterm neonate.
- •Preexisting neuromuscular disease
- •Sacral/vertebral abnormalities
- •Congenital anomaly.
- •(Include specifically sacral anomalies/vertebral abnormalities, meningomyelocele, spina bifida, cauda equina)
- •Bleeding diathesis.
结局指标
主要结局
duration of postoperative analgesia
时间窗: 5 min intervals at the time of caudal delivery of drug till 2 hours in PACU, then every 2 hours till 24 hours postoperatively
次要结局
- 1) Incidence of bradycardia.(2) Incidence and severity of Post operative sedation and agitation.)
研究者
Dr Shubhdeep
Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar