Comparative Evaluation of Intrathecal Butorphanol and Dexmedetomidine as an Adjuvant to Hyperbaric Ropivacaine in Subarachnoid Block.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Time of onset of sensory and motor blockade (assessed using pinprick method and Modified Bromage scale respectively)
研究概览
简要总结
This prospective, randomized, double-blind controlled trial aims to compare the effects of intrathecal butorphanol and dexmedetomidine as adjuvants to 0.75% hyperbaric ropivacaine in patients undergoing infraumbilical surgeries under spinal anaesthesia.
A total of 75 adult patients (ASA I–II) aged 18–60 years will be randomly assigned into three groups:
Group RB: Ropivacaine + Butorphanol (100 mcg)
Group RD: Ropivacaine + Dexmedetomidine (10 mcg)
Group RN: Ropivacaine + Normal Saline (control)
Primary outcome includes onset time of sensory and motor blockade. Secondary outcomes include duration of block, hemodynamic parameters, time to first rescue analgesic, and incidence of adverse effects. Patients will be monitored intraoperatively and for 24 hours postoperatively. The study will be conducted at Sharda Hospital, Greater Noida over 18 months.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients scheduled for infraumbilical surgery under subarachnoid block.
- •ASA Physical Status Grade I and II.
- •Age between 18 to 60 years.
- •Both male and female patients.
排除标准
- •Morbid obesity Patient with history of adverse response to study drugs Patient with pre-existing neurological or spinal disease, cardiovascular disease, renal, hepatic or any other systemic disease Contraindications for spinal anaesthesia like: Raised ICP, local site infections & spinal deformities like kyphosis and scoliosis Pregnant females Coagulopathy or bleeding diathesis.
结局指标
主要结局
Time of onset of sensory and motor blockade (assessed using pinprick method and Modified Bromage scale respectively)
时间窗: Every 1 minute until complete onset, then monitored intraoperatively
次要结局
- To compare the duration of sensory and motor blockade assessed by pin prick, Visual Analog Score (VAS) and modified Bromage scale respectively.(Changes in vitals parameters-heart rate (HR), noninvasive blood pressure (NIBP), and oxygen saturation (SPO2) intra operatively.)
研究者
Dr Apurva Tandon
School of Medical Sciences and Research Sharda University