Impact of Enhanced Recovery After Surgery (ERAS) for Sleeve Gastrectomy on Postoperative Nausea and Vomiting: Controlled Randomized Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The incidence of postoperative nausea and vomiting
研究概览
简要总结
The use of bariatric surgery in the treatment of severe obesity has several benefits in terms of sustainable weight loss, improvements, or resolution of several metabolic comorbidities as well as improved life expectancy.
Gastric surgery, history of acid reflux and reduction in gastric size, in particular after laparoscopic sleeve gastrectomy (LSG), surgery may further contribute to postoperative nausea and vomiting (PONV).
The combination of antiemetic drugs that act at different receptors is more effective than using only one drug in preventing PONV in patients with increased risk for these events.
详细描述
After obtaining Institutional Ethical Committee approval and written informed consent from the patients in each case, the ASA score, Simplified Apfel scores14 a measure of PONV risk, and duration of preoperative fasting are calculated for each patient. Patients will be randomly allocated into two groups.
Group 1 (non-ERAS): All patients will receive haloperidol 2 mg, dexamethasone 8 mg, and ondansetron 8 mg in addition to standard care protocol.
Group 2 (ERAS): All patients will receive haloperidol 2 mg, dexamethasone 8 mg, and ondansetron 8 mg in addition to following the recommendation of ERAS society guidelines.
All patients will receive general anesthesia. The doses of anesthetic drugs for induction and maintenance of anesthesia are calculated with reference to the ideal body weight (IBW) and the corrected body weight (CBW) in patients, where IBW=height (in cm)-100 for men and height (in cm)-105 for women and CBW=IBW+ [0.4 × (current weight-ideal weight)]12.
Anesthesia and Operative Technique for Non-ERAS:
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •* Age: 18-60 years
- •Sex: Both sex
- •ASA Physical Status: II, III.
- •Body mass index: Between 40 and 60 kg/m
- •Participants: Patients who are undergoing elective Sleeve Gastrectomy
排除标准
- •Patients with hypersensitivity or contraindication to haloperidol, dexamethasone, or ondansetron.
- •Serious complications in the perioperative period (such as shock, cardiac arrest, hemorrhage, needing transfusion).
- •Psychiatric disorder.
- •History of migraine.
- •Use of opioid, hormonal, anti-inflammatory, and antiemetic medication 24 h prior to surgery.
结局指标
主要结局
The incidence of postoperative nausea and vomiting
时间窗: 36 hours
number and percentage of episode of nausea and vomiting : I = no nausea or vomiting, II = nausea but no vomiting, III = mild to moderate vomiting, and IV = severe and frequent vomiting more than five times within 24h. The severity of postoperative nausea (PON) was assessed using a numeric rating scale (I = mild, II = mod¬erate, III = severe).
次要结局
- Time to tolerate oral fluid(36 hours)
- postoperative opioid consumption.(36 hours)
- Time to first administration of rescue antiemetic drug.(36 hours)
- The quality of recovery.(36 hours)
- complications.(36 hours)
研究者
haidy salah mansour
assistant professor of anesthesia and ICU
Minia University