The Evaluation of Adding Melatonin to Opioid Free Anesthesia on Postoperative Pain in Obese Patients Undergoing Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Postoperative Pain.
研究概览
简要总结
Opioid free anesthesia (OFA) means a technique in which no intraoperative opioid is administered through any route. Perioperative pain management in an obese patient is challenging. The incidence of respiratory depression is higher in obese patients and is exaggerated with opioids, so the investigators are searching for a drug that has analgesic effect without any effect on respiratory function. In this study, the investigators will add melatonin to OFA in obese patients undergoing laparoscopic cholecystectomy.
详细描述
Obesity leads to a restrictive lung disease, causing reduction in functional residual capacity and total lung compliance.
When an obese patient is supine and anesthetised, the depressant effects of many anesthetic agents and analgesics, particularly opioids, further decrease the lung compliance, leading to increased hypoxemia.
Opioid based general anesthesia in these patients increases the incidence of postoperative respiratory depression, atelectasis, and pneumonia. Also, pain relief with opioids is associated with sedation, hence impeding rapid recovery and early mobilization.
OFA is the use of multimodal or balanced analgesia. The principle of this is to gain additive analgesic effects from different drugs while minimizing side effects, particularly those of opioids. Studies have shown that OFA fast tracks surgery, reduces hospital stay, promotes early mobilization, and enteral nutrition.
Prior studies which investigated opioid free techniques are based on the combination of drugs acting on sympathetic nervous system, perioperative administration of local anesthetics, nonsteroidal anti-inflammatory drugs, and of adjuvant drugs, such as ketamine, magnesium etc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-45 years.
- •Body Mass Index: Over 30 kg/m
- •Physical Status: ASA classification I and II.
排除标准
- •Patient refusal.
- •Age: Less than 18 years, more than 45 years.
- •Patients with known history of allergy towards one of the study drugs.
- •Patients with severe cardiac, respiratory, hepatic or renal disease.
- •Body Mass Index: Under 30 kg/m2.
研究组 & 干预措施
The Melatonin group
Melatonin group: A total of 30 obese patients undergoing laparoscopic cholecystectomy will receive melatonin oral (0.2 mg /kg) 45 minutes before general anesthesia.
干预措施: Melatonin (Drug)
The Control group
Control group: A total of 30 obese patients undergoing laparoscopic cholecystectomy will receive placebo medication (Vitamin Supplement) 45 minutes before general anesthesia; Control group.
干预措施: Vitamin Supplement (Dietary Supplement)
结局指标
主要结局
Postoperative Pain.
时间窗: Will be evaluated postoperatively at time of delivery to Post Anesthesia Care Unit (PACU) (Zero time) and every 5 minutes for 30 minutes.
Numeric Rating Scale (NRS); is a pain screening tool, commonly used to assess pain severity at that moment in time using a (0-10) scale, with (0) meaning no pain and (10) meaning the worst pain imaginable.
次要结局
- Recovery time.(Will be evaluated at time of admission to PACU and every 15 minutes for 1 hour until being discharged from it.)
- Postoperative nausea and vomiting.(Will be evaluated postoperatively (Zero time) and every 15 minutes for 1 hour.)
- Postoperative Pain.(Will be evaluated at time of 30 minutes after delivery to PACU and hourly for 4 hours.)
- Analgesics usage.(Will be evaluated postoperatively (Zero time) and every 15 minutes for 1 hour.)
- Number of participants with hemodynamic instability.(Will be evaluated at the start of the operation and every 5 minutes throughout the operation until delivery to PACU and every 15 minutes for 1 hour until being discharged from it.)
研究者
Ismail Farid Ibrahim Mahmoud
Assistant Lecturer of Anesthesia
Ain Shams University