Impact of Preoperative Aripiprazole on Postoperative Analgesia in Laparoscopic Hysterectomy: A Randomized Controlled Clinical Trial
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 analgesic effect of perioperative use of aripiprazole has not been fully investigated.
So, this study aims to test the effects of aripiprazole versus placebo in reducing postoperative pain following laparoscopic hysterectomy and to explore the potential side 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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Physical status American Society of Anesthesiologist (ASA) I or II
- •Electively scheduled for laparoscopic hysterectomy,
排除标准
- •Patients who refuse to participate
- •Body mass index (BMI) > 30
- •ASA physical status > II
- •Major illnesses (e.g., cardiac, respiratory, renal, hepatic or neurological)
- •Coagulation abnormalities
- •Pregnancy
- •Known hypersensitivity to aripiprazole or contraindications to its use (a psychiatric illness, patients on antidepressants, dementia-related psychosis)
- •History of drug addiction or alcohol abuse
- •Mental retardation interfering with the evaluation of pain scores or PCA programs .
研究组 & 干预措施
Aripiprazole
Patients will receive Aripiprazole 30 mg tablet orally 3 h before surgery
干预措施: ARIPiprazole 30 MG (Drug)
Placebo
Patients will receive placebo tablet which is identical in appearance, size, shape, and color to aripiprazole 3 h before surgery.
干预措施: Placebo (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
Associate Professor
Ain Shams University