Comparison of Analgesic Efficacy and Occurrence of Emesis Among Different Background Infusion and Bolus Administration Regimens of Fentanyl Based Intravenous Patient-controlled Analgesia in Patients After Laparoscopic Assisted Gastrectomy - a Randomized Blind Study -
试验速览
- 阶段
- 不适用
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Pain score(VAS) within 48hrs after surgery
研究概览
简要总结
Fentanyl based intravenous patient controlled analgesia(PCA)is popular method for postoperative pain control, but information regarding optimal dose of fentanyl in IV PCA is currently lacking. We thus determine appropriate dose of fentanyl (bolus dose and background infusion rate) for effective pain control with minimal side effects such as 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
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20 and 70
- •ASA class I and II
- •Gastric cancer patients who are scheduled to receive laparoscopic gastrectomy
排除标准
- •Cardiovascular disease(uncontrolled hypertension, unstable angina, congestive heart failure, etc.)
- •Renal failure
- •Liver failure
- •Chronic drug or alcohol abuser
- •Anti-cancer chemotherapy
- •Chronic opioid use
- •Use of antiemetics within 24hrs for nausea and vomiting
研究组 & 干预措施
B0
(basal rate 0cc/hr, bolus 3cc, lockout time 10min)
干预措施: B0 group: bolus 0.6mcg/kg without background infusion (Drug)
BL
(basal rate 1cc/hr, bolus 2cc, lockout time 10min)
干预措施: BL group: bolus 0.4mcg/kg with background infusion rate 0.2mcg/kg/hr (Drug)
BH
(basal rate 2cc/hr, bolus 1cc, lockout time 10min)
干预措施: BH group: bolus 0.2mcg/kg with background infusion rate 0.4mcg/kg/hr (Drug)
结局指标
主要结局
Pain score(VAS) within 48hrs after surgery
时间窗: Pain socre after surgery 1) within 30min-6hrs, 2) within 6-24hrs, 3) within 24hrs-48hrs
Pain score after surgery within 48hrs after laparoscopic gastrectomy
次要结局
未报告次要终点