Dexamethasone Dose for Postoperative Nausea and Vomiting Prophylaxis in Obese Patients
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- postoperative nausea and vomiting (PONV)
研究概览
简要总结
compare the effectiveness of different doses of dexamethasone used for postoperative nausea and vomiting prophylaxis in obese patients and in normal weight patients.
详细描述
compare the effectiveness of different doses of dexamethasone used for postoperative nausea and vomiting prophylaxis in obese patients.
compare the effectiveness of dexamethasone given in 4 mg and 8 mg doses in obese patients with 4 mg doses of dexamethasone in normal weight patients.
4 mg iv dexamethasone will be administered to normal weight patients at induction of anesthesia. This group will be classified as the control group. In obese patients (BMI>30 kg/m2), one group will receive 4 mg dexamethasone and other group will receive 8 mg dexamethasone at induction.
Patients will receive general anesthesia with volatile anesthetics and tramadol will be administered IV at the end of surgery.
Postoperative nausea and vomiting, postoperative pain, blood glucose, wound infection, time to oral intake, hospital stay will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •High risk patients for postoperative nausea and vomiting:
- •No smoking
- •BMI =18.5-24.9 for control group
- •BMI >30 for other groups
- •undergo laparoscopic cholecystectomy
排除标准
- •Diabetes mellitus
研究组 & 干预措施
control
patients with BMI=18.5-24.9 kg/m2 will be received 4 mg dexamethasone at induction of anesthesia for postoperative nausea and vomiting prophylaxis.
干预措施: Dexamethasone 4 mg IV-control (Drug)
4 mg
patients with BMI>30 kg/m2 will be received 4 mg dexamethasone at induction of anesthesia for postoperative nausea and vomiting prophylaxis.
干预措施: Dexamethasone 4 mg IV (Drug)
8 mg
patients with BMI>30 kg/m2 will be received 8 mg dexamethasone at induction of anesthesia for postoperative nausea and vomiting prophylaxis.
干预措施: Dexamethasone 8 mg IV (Drug)
结局指标
主要结局
postoperative nausea and vomiting (PONV)
时间窗: PONV scores wİll be record during the first 24 hours
The primary outcome is the overall incidence of PONV during the first 24 h, defined as any episode of vomiting or nausea.Nausea will be measured using an 11-point verbal rating scale (VRS) running from 0 (no nausea) to 10 (the worst nausea imaginable). We will define severe PONV as nausea with a score of at least 4 on the VRS, or vomiting.
次要结局
- Length of Hospital Stay(during the first 24 hours)
- postoperative pain: 11-point VRS(Pain will be assessed during the first 24 hours)
- blood glucose(at 6 and 10 hours after administration of dexamethasone)
- wound infection(postoperative 30th day)
- oral intake(during the first 24 hours)
研究者
Bahar SAKIZCI UYAR
medical doctor
Diskapi Yildirim Beyazit Education and Research Hospital