Randomized Controlled Trial of the Effect of General Anesthetics on Postoperative Recovery After Minimally Invasive Nephrectomy (REGAIN Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- quality of recovery
研究概览
简要总结
This prospective, randomized, single-blinded study is designed to compare the postoperative quality of recovery between propofol based total intravenous anesthesia and desflurane in patients undergoing minimally invasive nephrectomy. We hypothesize that propofol based total intravenous anesthesia can significantly improve the quality of recovery after surgery in patients with minimally invasive nephrectomy.
详细描述
Adult patients undergoing elective laparoscopic or robotic assisted nephrectomy are randomly allocated to receive propofol based total intravenous anesthesia (n=75) or desflurane (n=75). The quality of recover after surgery using the QoR-15K was assessed by a investigator at postoperative day (POD) 1, 2, and 3. The primary outcome is the QoR-15K at POD 1, 2, and 3 after surgery.
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
- Single (Participant)
盲法说明
Patients will receive general anesthesia, therefore they can not know their anesthetic method.
Physicians involved in this study will investigate the outcomes.
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled to undergo elective laparoscopic or robotic assisted nephrectomy under general anesthesia
- •American Society of Anesthesiologists (ASA) physical classification I-II
- •Willingness and ability to sign an informed consent document
排除标准
- •Do not understand our study
- •American Society of Anesthesiologists (ASA) physical classification III or more
- •Allergies to anesthetic or analgesic medications
- •Chronic pain, chronic analgesic or antidepressant or anticonvulsant use
- •Medical or psychological disease that can affect the treatment response
- •Patients who receive mechanical ventilation more than 2 hours after surgery
研究组 & 干预措施
TIVA group
Patients receiving total intravenous anesthesia with propofol.
干预措施: total intravenous anesthesia with propofol (Drug)
Desflurane group
Patients receiving inhalation anesthesia with desflurane.
干预措施: inhalation anesthesia with desflurane (Drug)
结局指标
主要结局
quality of recovery
时间窗: at 24 hours, 48 hours, 72 hours postoperatively
Change in the QoR-15K score from 24 hours to 72 hours postoperatively
次要结局
- Postoperative nausea and vomiting during the first 24 hours postoperatively(during the first 24 hours postoperatively)
- Postoperative pain score(at 24 hours, 48 hours, 72 hours postoperatively)
- Postoperative nausea and vomiting during the 48-72 hours postoperatively(during the 48-72 hours postoperatively)
- Total fentanyl consumption during the first 24 hours postoperatively(during the first 24 hours postoperatively)
- Quality of life at early post-discharge(day before surgery and at 3 weeks after discharge)
- Postoperative nausea and vomiting during the 24-48 hours postoperatively(during the 24-48 hours postoperatively)
- Total fentanyl consumption during the 24-48 hours postoperatively(during the 24-48 hours postoperatively)
- Total fentanyl consumption during the 48-72 hours postoperatively(during the 48-72 hours postoperatively)
研究者
Hojin Lee, MD
Assistant professor
Seoul National University Hospital