Comparison of paracetamol and paracetamol-dexmedetomidine combination on postoperative pain and postoperative nausea and vomiting after elective laparoscopic hysterectomy surgery: a randomized 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
- VAS Scoring and postoperative analgesic requirement
研究概览
简要总结
Postoperative analgesic requirement and nausea & vomiting are common and distressing complaints after general anesthesia in laparoscopic surgery. Postoperative nausea and vomiting (PONV) incidence as high as 60-80% in high risk patients in laparoscopic surgeries. Use of opioids in postoperative period for pain relief is a high risk factor for PONV. So avoidance of opioids and use of paracetamol is another alternative for pain relief. But paracetamol alone is not effective for adequate pain relief. So we designed a study to compare the effectiveness of paracetamol and paracetamol dexmedetomidine combination for reduction of analgesic requirement and prevention of PONV in laparoscopic surgery. All selected patients will be randomized in to two groups (40 patients in each group) depending on the drug given.
Group P - received paracetamol 4.5 mg/kg bolus dose over 15 min then demand dose 1 mg/kg/hr with 30 min lockout interval and continuous dose 0.5 mg/kg/hr
Group PD - received paracetamol 4.5 mg/kg and dexmedetomidine 1 mcg/kg dose over 15 min, then demand dose paracetamol 1 mg/kg/hr (dexmedetomidine 1 mcg/kg/hr) with 30 min lockout interval and continuous dose paracetamol 0.5 mg/kg/hr (dexmedetomidine 0.05 mcg/kg/hr)
Primary outcome - VAS score at 1, 2, 4, 6 and 12 hr in postoperative period and analgesic requirement in first 24 hr period
Secondary outcome - PONV incidence in first 24 hr postoperative period
Statistically analysis will be done after completion of study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •ASA grade I and II
- •Scheduled for laparoscopic gynaecological surgery under general anesthesia.
排除标准
- •1.Known allergy to study drugs 2.Use of antiemetic drugs within 24 hrs of surgery 3.Morbid obesity(BMI>40) 4.Chronic use of opioids 5.Patients with hepatic,renal or cardiovascular dysfunction 6.Psychiatric patients.
结局指标
主要结局
VAS Scoring and postoperative analgesic requirement
时间窗: VAS Scoring at 1,2,4,6 and 12th hour and analgesic | requirement in first 24 hour
次要结局
- Postoperative nausea and vomiting(24 hr postoperative period)