Impact of Propofol-Based Total Intravenous Anesthesia Versus Anesthesia With Sevoflurane
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
This is a two-arm, parallel-group randomized clinical trial. Routine perioperative care would be performed in volunteers with primary Hepatocellular carcinoma. The study will enroll approximately 500 volunteers to compare the progression-free or overall survival in patients undergoing elective partial hepatectomy for primary liver tumors between propofol and sevoflurane for the maintenance of anesthesia.
详细描述
Before the scheduled procedure, the patients are randomly assigned into peopofol group or groups (1:1) according to the randomization generated by the computer. Both groups were induced with propofol 1~2.5 mg/kg propofol. The propofol group was maintained at an effect-site concentration of 2.0-4.0 mcg/mL by a target-controlled infusion system. The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3 MAC). During the operation, the dose of anesthetic drugs (propofol/fentanyl /remifentanil and sevoflurane/cisatracurium/rocuronium) are adjusted to maintain the mean arterial pressure and heartbeat fluctuations within 20% of the baseline value and Entropy (or BIS) value at 40-60in both groups. The following patient data were recorded, the type of anesthesia, sex, age at the time of surgery, preoperative Karnofsky performance status score and functional capacity, the postoperative complications within 30 days (according Clavien-Dindo classification), American Society of Anesthesiologists physical status scores, tumor size, intraoperative blood loss/transfusion, duration of surgery, duration of anesthesia, total opioid (remifentanil/fentanyl/ propofol) use, postoperative radiation therapy, postoperative chemotherapy, postoperative concurrent chemoradiotherapy, the presence of disease progression, and 6-month, 1-year, and 3-year overall survival and Karnofsky performance status score were recorded.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Twenty to eighty-year-old.
- •ASA class I-III.
- •Patients undergoing partial hepatectomy for hepatocellular carcinoma under general anesthesia.
排除标准
- •Severe mental disorder
- •Pregnant or lactating women
- •Morbidly obese
- •Allergy to any of the drugs used in this study
- •Recurrent tumor or repeat surgery
- •Biopsy cases
- •Incomplete data collection before the surgery
- •Palliative treatment after surgery
- •simultaneous treatment of other malignancies
- •Combined propofol and inhalation anesthesia or other anesthetics, such as ketamine or dexmedetomidine
- •Diagnosed as benign liver tumor
- •Emergency surgery
研究组 & 干预措施
Propofol Group
The propofol group was maintained at an effect-site concentration (Ce) of 2.0-4.0 mcg/mL by a target-controlled infusion (TCI) system.
干预措施: Propofol (Drug)
Sevoflurane group
The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3 MAC).
干预措施: Sevoflurane (Drug)
结局指标
主要结局
Overall survival
时间窗: From the date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months"
6-month overall survival, 1-year overall survival, and 3-year overall survival
The presence of disease progression
时间窗: From the date of surgery until the date of first documented progression (recurrence or metastasis),assessed up to 36 months
From the date of surgery until the date of first documented progression (recurrence or metastasis) or date of death from any cause, assessed up to 36 months"
次要结局
- Postoperative complications(The period from the day of surgery to postoperative 30 days)
- Karnofsky performance status score(Karnofsky performance score(from 0 (dead) to 100(normal no complication)) before surgery (baseline data) , postoperation 7 days, postoperation 3 months, postoperation 6 months, postoperation 12 months)
- Length of hospital stays(from the day of surgery to dischage, assessed up to 30 days)