A comparison of effects of intravenous dexmedetomidine and paracetamol in bupivacaine spinal anesthesia in lower abdominal and pelvic surgeries.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- 1.To compare the effects of intravenous dexmedetomidine and paracetamol on duration and quality of bupivacaine spinal anaesthesia in lower abdominal and pelvic surgeries.
研究概览
简要总结
This study is a prospective, double-blind, randomized, placebo controlled trial to compare the effects of intravenous dexmedetomidine and paracetamol on duration and quality of bupivacaine spinal anaesthesia in lower abdominal and pelvic surgeries. We aim to compare the effectiveness of the above drugs compared with placebo given 15 minutes before performing subarachnoid block on duration and quality of sensory block, motor block, and post operative analgesic requirement
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
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •American Society of Anesthesiologists (ASA) class I or II
- •Age: 18 to 70 years
- •Measuring 150-180 cm height, with body mass index (BMI) of 18-35 kg/m2
- •Patients undergoing elective lower abdominal and pelvic surgeries requiring spinal anaesthesia (maximum surgery duration-2hours).
排除标准
- •All contraindications to spinal analgesia including bleeding diathesis, infection at the puncture site, spinal deformity, patient on anticoagulants, pre-existing neurological deficits in lower extremities, unwillingness to give consent.
- •Sensory blockade inadequate for surgery.
- •Patients on alpha-2 adrenergic receptors antagonists, calcium channel blockers, or angiotensin-converting enzyme inhibitors.
- •Patients having cardiac rhythm abnormalities.
- •History of alcoholism, drug abuse, and psychiatric disorders.
- •Hepatic disease, renal disease, cardiopulmonary disease, hypertension, diabetes, central or peripheral nervous system disorders.
- •Laparotomy, chronic abdominal pain undergoing treatment with opioid analgesic.
- •Pregnant patients.
- •Orthopaedic surgeries.
- •Surgeries extending more than 2 hours.
结局指标
主要结局
1.To compare the effects of intravenous dexmedetomidine and paracetamol on duration and quality of bupivacaine spinal anaesthesia in lower abdominal and pelvic surgeries.
时间窗: Intra-operatively - | 1. Time of T10 sensory block | 2. Maximal sensory block achieved | 3. Time of Bromage 3 motor block | Post-operatively - | 1. Time to sensory regression (2 dermatomes) | 2. Time to motor regression | (Bromage 1) | 3. Time of first analgesic dose (VAS 3)
次要结局
- To assess the sedation score and adverse effects(1. Sedation assessed by Modified Ramsay sedation scale.)