Adding Dexmedetomidine Versus Fentanyl to Bupivacaine for Epidural Analgesia in Combination With General Anesthesia for Elective Lumbar Disc Operations: Prospective, Randomized Double-blinded Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- First time to analgesic requirement
研究概览
简要总结
The purpose of this study is to compare addition of dexmedetomidine or fentanyl to bupivacaine for epidural analgesia in combination with general anesthesia in elective lumbar spine operations as regard hemodynamic stability, postoperative pain control and adverse effects.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physical status American Society of Anesthesiologist (ASA) I or II.
- •First time elective lumbar dicsectomy or laminectomy
排除标准
- •Patients who refuse to participate
- •Body mass index (BMI) > 30
- •Need an emergency lumbar disc operation
- •ASA physical status > II
- •Major illnesses (e.g. cardiac, respiratory, renal, liver)
- •Coagulation abnormalities
- •Hypovolemia
- •History of increased intracranial pressure
- •Convulsions
- •Spinal stenosis
- •Infection at needle insertion site
- •Other contraindications to epidural procedure
- •Allergy or contraindications to the drugs used in the study
- •History of addiction or alcohol abuse
- •Psychiatric illness or mental retardation
研究组 & 干预措施
Group BF
Bupivacaine plus Fentanyl
干预措施: Bupivacaine (Drug)
Group BF
Bupivacaine plus Fentanyl
干预措施: Fentanyl (Drug)
Group BD
Bupivacaine plus Dexmedetomidine
干预措施: Bupivacaine (Drug)
Group BD
Bupivacaine plus Dexmedetomidine
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
First time to analgesic requirement
时间窗: First 24 hours postoperatively
After extubation, an intravenous patient-controlled analgesia system, will be connected to the patient (Accufuser Plus® 100 ml, Woo Young Medical Co, Korea) will be prepared with 60 ml normal saline containing 60 mg morphine, it will be programmed to give and 0.5 ml bolus dose with lockout interval of 8 minutes. Time to first Bolus will be estimated considering extubation time is the zero time.
次要结局
- Total opioid consumption(First 24 hours postoperatively)
- Visual analogue scale (VAS)(First 24 hours postoperatively)
研究者
Amin Mohammed Alansary Amin Ahmed Helwa
Assistant Professor
Ain Shams University