Effect of Opioid Free Anesthesia in Patients Undergoing Laparoscopic Gastrectomy: Subgroup Analysis Based on Psychological Trait
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Opioid consumption in postoperative 24hrs
研究概览
简要总结
The investigator will examine the effects of opioid free anesthesia in patients undergoing laparoscopic gastrectomy. The investigator expect that opioid free anesthesia will reduce postoperative pain and opioid consumption.
And investigator will analyze the association between postoperative pain and patient's underlying psychological characteristics and pain sensitivity. The investigator anticipate that psychological characteristics and pain sensitivity may be realted to postoperative pain and opioid consumption.
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
- Single (Participant)
盲法说明
Patients don't know which group they belong to.
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 19 years who underwent laparoscopic gastrectomy for gastric cancer
排除标准
- •Patients with a history of allergic reactions to drugs
- •Patients with a history of drug addiction
- •Patients with chronic pain who require analgesics
- •Patients with cancer other than the stomach
- •History of hospitalization for psychiatric disorders
- •Patients with sleep apnea
- •Preoperative pulse oximetry (SpO2) < 95 %
- •Moderate or severe hepatic impairment
- •bradycardia (HR<50bpm), hypotension, atrioventricular block, intraventricular or sinus block
- •Body mass index over 35 kg/m2
- •Blood clotting disorders
- •Pregnant/lactating women
- •Cognitive impairment
- •Unable to read consent form (eg illiterate, foreigner, etc.)
研究组 & 干预措施
OFA group
Dexmedetomidine and lidocaine are administered during anesthesia, and opioid is not used. For induction, 1 μg/kg of Dexmedetomidine is administered over 10 minutes and 1mg/kg of lidocaine is administered intavenously (bolus). This is followed by continuous intravenous infusion of dexmedetomidine at a rate of 0.2-0.7 μg/kg/h and infusion of lidocaine at the rate of 1 mg/kg/h.
干预措施: OFA (Drug)
Control group
Remifentanil is infused during anesthesia, and target-controlled infusion (TCI) is performed according to the Minto model. During indcution of anestheisa, target concentration of remifentanil is set within 3-5 ng/mL. After intubation, target concentration is adjusted within the range of 2-8 ng/mL.
干预措施: Control (Drug)
结局指标
主要结局
Opioid consumption in postoperative 24hrs
时间窗: 24 hours after surgery
Total opioid dose administered to the patient.
次要结局
- Time to rescue analgesics after surgery(up to 2weeks)
- Hemodynamics during surgery(during surgery)
- PCL-5(postoperative 1week)
- Nausea score(postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days)
- Number of vomiting, antiemetic adeministration(up to 2weeks)
- Opioid consumption(postoperative 6hours, 12hours, 36hours, 48hours, 3days, 4days, 5days)
- QoR-15(1-5 days before surgery, postoperative 1day, postoperative 4day)
- Time to bowel function recovery (Gas passing time, Fluid intake start time, Soft diet start time)(up to 2weeks)
- Pain score(postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days, 2weeks)
研究者
Young Song
Professor
Gangnam Severance Hospital