Comparative evaluation of epidural and intravenous dexmedetomidine as adjuvants for prolonging post operative analgesia in adults undergoing infraumbilical surgery under combined spinal epidural anaesthesia
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To compare the duration of postoperative analgesia by observing the time of request for the first rescue analgesic dose.
研究概览
简要总结
This prospective, randomized, comparative study will assess the effect of dexmedetomidine when given by two routes—epidural or intravenous—as an adjuvant to bupivacaine in adults undergoing infraumbilical surgery under combined spinal epidural anaesthesia. Ninety patients aged 18–65 years (ASA I–II) will be included. The primary outcome is the duration of postoperative analgesia, measured by time to first rescue analgesic. Secondary outcomes include sedation using Modified Ramsay Sedation Score and perioperative hemodynamic changes, assessed over 24 hours.
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
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients aged between 18 and 65 years, belonging to American Society of Anesthesiologists (ASA) physical status I or II, scheduled to undergo elective infraumbilical surgery under combined spinal epidural anaesthesia.
排除标准
- •Patients with known hypersensitivity or allergy to local anaesthetics or dexmedetomidine.
- •Patients with baseline bradycardia (heart rate less than 50 bpm) or baseline systolic BP less than 90 mmHg.
- •Patients on beta-blockers or alpha-2 agonists.
- •Patients with any contraindications to regional anaesthesia.
- •Patients with a history of chronic opioid use or long-term analgesic therapy.
- •Patients with psychiatric illness or cognitive impairment affecting consent or pain assessment.
结局指标
主要结局
To compare the duration of postoperative analgesia by observing the time of request for the first rescue analgesic dose.
时间窗: The primary outcome (duration of postoperative analgesia) will be assessed at predefined intervals — 1, 2, 4, 6, 8, 12, 18, and 24 hours after administration of the study drug, and additionally at the time of first rescue analgesic request.
次要结局
- Postoperative sedation score(Modified Ramsay Sedation Score, MRSS)(postoperatively at 1st hour, 2nd hour, 4th hour, 8th hour and 24th hour)
- Hemodynamic parameters( heart rate, blood pressure,SpO2).(baseline vitals after wheeling in other. administration of drug ( time zero), 15 minutes, 30 minutes, 30 minutes, 45 minutes, 1st hour, 1.5 hour , 2nd hour, 4th hour, 8th hour and 24th hour)
研究者
Urmi Ganguly
Vardhman Mahavir Medical College and Safdarjung Hospital