Comparison of Postoperative Recovery Between Dual-channel Pump for Intravenous Patient-controlled Analgesia(IV-PCA) and Conventional Single-channel Pump After Laparoscopic Sleeve Gastrectomy: a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- postoperative nausea and vomitting
研究概览
简要总结
Postoperative nausea and vomiting (PONV) are the most common complications that can occur after general anesthesia. Postoperative use of opioids and morbid obesity have been reported as risk factors of PONV. In this study, the investigators aimed to compare the degree of postoperative side effects and pain control when an intravenous patient-controlled analgesia combining fentanyl and ketorolac via a dual-chamber device was provided to participants undergoing laparoscopic sleeve gastrectomy.
详细描述
Morbidly obese patients undergoing laparoscopic sleeve gastrectomy experience a relatively high incidence of postoperative nausea and vomiting, but no effective treatment method has been established yet to prevent them. Through this study, the investigators can expect that if a dual-chamber patient-controlled analgesia device can provide effective analgesia while reducing the amount of opioid used, and thus reduce postoperative nausea and vomiting, it can have the effect of increasing the quality of recovery and satisfaction of participants who have undergone laparoscopic sleeve gastrectomy. Furthermore, this dual-chamber patient-controlled analgesia device can be applied to various surgeries and various patient groups who are at risk for postoperative nausea and vomiting, and it is expected that it can be adapted as one of the methods to prevent postoperative nausea and vomiting.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult females aged 19 to 65 years
- •American Society of Anesthesiologists physical status (ASA class) 1 to 3
- •Patients scheduled for laparoscopic sleeve gastrectomy under general anesthesia
- •Patients requesting the use of IV-PCA after surgery
排除标准
- •Patients with hypersensitivity to the drugs used in this study (Ketorolac, Fentanyl)
- •Patients with alcohol or drug dependence, long-term use of opioids or analgesics
- •Patients with liver disease or renal failure
- •Patients with peptic ulcer, patients with gastrointestinal bleeding predisposition
- •Patients with suspected cerebrovascular hemorrhage, organic disorders of the head related to increased intracranial pressure
- •Patients with bronchial asthma or bronchospasm symptoms
- •Patients with severe respiratory depression
- •Nasal polyps, angioedema
- •Patients with or history of convulsive disease
- •Patients for whom the use of neuromuscular blocking agents is contraindicated
研究组 & 干预措施
dual-chamber PCA
干预措施: multimodal analgesia via dual-chamber PCA (Device)
single regimen PCA
干预措施: single regimen (only fentanyl) (Device)
结局指标
主要结局
postoperative nausea and vomitting
时间窗: postoperative 1 day
The Quality of Recovery score 15
次要结局
未报告次要终点
研究者
Park InSun
Principal investigator
Seoul National University Bundang Hospital