The Effect of Intrathecal Versus Intravenous Dexmeditomedine on Postoperative Analgesia in Transurethral Resection of the Prostate
试验速览
- 阶段
- 4 期
- 入组人数
- 75
- 主要终点
- The time to first rescue analgesic
研究概览
简要总结
This study is to evaluate The analgesic effect of intrathecal versus intravenous dexmeditomedine in transurethral resection of the prostate
详细描述
This study will carried out in Tanta University hospital on75 male patients Patients will randomly classified into 3 groups Group I: will receive intrathecal hyperbaric bupivacaine 10mg in 2.5 ml and .5 ml saline with 3ml total volume Group II: will receive dexmeditomedine 5Mic diluted in.5 ml saline and hyperbaric bupivacaine 10mg in 2.5ml with 3ml total volume Group IIl: Will receive intravenous dexmeditomedine started at loading dose of 1 mic/kg diluted in 50 ml saline and administered within 10 min as loading dose , followed by maintenance at a dose of .4mic/kg/h diluted in200 ml saline till the end of surgery and hyperbaric bupivacaine 10 mg in 2.5 ml total volume
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 59 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •male gender
- •50:70years old
排除标准
- •contraindications of spinal anesthesia
- •Patient refusal
- •Patient taking alpha agonist or antagonist
- •Uncontrolled cardiac diseases
- •Allergy to local anesthetic drugs
研究组 & 干预措施
Control (Placebo) group
Each patient will receive intrathecal hyperbaric bupivacaine 10 mg in 2.5 ml and 0.5 ml saline with 3 mL total volume. Continous 50 ml saline infusion for 10 min followed by 200 ml saline infusion till the end of surgery.
干预措施: control group (Drug)
Intrathecal dexmedetomidine group
Each patient will receive dexmedetomidine 5 μg diluted in 0.5ml saline and hyperbaric Bupivacaine 10 mg in 2.5 ml with 3 mL total volume. Continous 50 ml saline infusion for 10 min followed by 200 ml saline infusion till the end of surgery.
干预措施: Intrathecal dexmedetomidine (Drug)
Intravenous dexmedetomidine group
Each patient will receive intravenous dexmedetomidine started at a loading dose of 1 μg/kg diluted in 50 ml saline and administered within 10 min as a loading dose, followed by maintenance at a dose of 0.4 μg/kg/h diluted in 200 ml saline till the end of surgery and hyperbaric Bupivacaine 10 mg in 2.5 ml total volume.
干预措施: Intravenous dexmedetomidine (Drug)
结局指标
主要结局
The time to first rescue analgesic
时间窗: 24 hours postoperative
The duration between the administration of spinal block and the first desire for supplemental analgesia (onset of 1st post-operative analgesic dose). First post-operative analgesic dose will be1 μg/kg intravenous fentanyl when visual analogue pain score (VAS) is 4 or more
次要结局
- Intraoperative and postoperative complications(Intraoperative and 24 hours postoperative)
- Postoperative pain score Total dose of analgesic consumption I the first postoperative day Intraoperative and postoperative complications(24 hours postoperative)
- Total analgesic consumption(24 hours postoperative)
研究者
Laila Elahwal
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine
Tanta University