NCT04908579招募中4 期
Efficacy of Preventive Ketamine on Postoperative Pain: A Randomized, Double-blind Trial of Patients Undergoing Laparoscopic Sleeve Gastrectomy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Time to first given rescue analgesia(minutes)
研究概览
简要总结
- Although bariatric surgery is mainly performed laparoscopically, analgesic optimization is still essential to reduce complications and to improve the patients' comfort. In laparoscopic sleeve gastrectomy, the intraoperative peritoneal instillation of bupivacaine hydrochloride (30 ml, 0.25%) was known to be safe and effective in reducing postoperative pain, nausea, and vomiting.
- Furthermore, usage of ketamine both as a pre and post-operative pain management is well established. Ketamine can be used solely or in combination with other co-adjuvant drugs, increasing their efficacy. Many therapeutic properties of ketamine have been attributed to its antagonism mechanism to N-Methyl-D-aspartate receptors.
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
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Body mass index > 35 and < 60 kg/m2
- •Either medically free or with well controlled hypertension and/or diabetes.
排除标准
- •- Patient's refusal to participate in the study
- •BMI > 60 kg/m
- •Age less than 21 years.
- •Patients with severe systemic disease which is not life-threatening.
- •Patients on antipsychotics, antidepressants and/or corticosteroids.
- •Patients with history of obstructive sleep apnea.
- •Allergic reaction to any of the study medications.
研究组 & 干预措施
- GROUP (I): 30 patients
Active Comparator
干预措施: bupivacaine(intraperitoneally) and ketamine (intraperitoneally) (Drug)
- GROUP (II): 30 patients
Active Comparator
干预措施: bupivacaine(intraperitoneally) and ketamine (intravenously) (Drug)
- GROUP (III) (Control): 30 patients
Active Comparator
干预措施: bupivacaine(intraperitoneally) (Drug)
结局指标
主要结局
Time to first given rescue analgesia(minutes)
时间窗: 24 hours postoperatively
Time to first given rescue analgesia(minutes)
次要结局
未报告次要终点
研究者
Ibrahim Mamdouh Esmat
Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.
Ain Shams University
研究点 (1)
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