Impact of Propofol-Based Total Intravenous Anesthesia Versus Anesthesia With Sevoflurane on Long-term Outcomes With Patients Undergoing Elective Surgery for Primary Ovarian Cancer
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 416
- 试验地点
- 1
- 主要终点
- progression-free survival
研究概览
简要总结
Ⅶ. Study procedures (summary)
- Written informed consent must be obtained before any study specific procedures are undertaken.
Qualified participants were identified at the pre-anesthesia evaluation clinic or ward. The informed consents are obtained from the patient in the ward at night before the operation. 2. The process of the experiment (brief describe) In the preoperative waiting area, the patients are randomly assigned and divided into two groups according to the allocation sequence table (corresponding to 1:1 randomization) generated by the computer. The propofol group was both induced and maintained at an effect-site concentration (Ce) of 2.0-4.0 mcg/mL by a target-controlled infusion (TCI) system. The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3). 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 (KPS) score and functional capacity, the postoperative complications within 30 days (according Clavien-Dindo classification), ASA physical status scores, tumor marker ,tumor size, intraoperative blood loss/transfusion, duration of surgery, duration of anesthesia, total opioid (remifentanil/fentanyl) use, postoperative radiation therapy, postoperative chemotherapy, postoperative concurrent chemoradiotherapy, the presence of disease progression, and 6-month, 1-year, 3-year and 5-year overall survival and Karnofsky performance status score were recorded.
详细描述
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, age at the time of surgery, preoperative Karnofsky performance status (KPS) score and functional capacity, the postoperative complications within 30 days (according Clavien-Dindo classification), ASA physical status scoress, tumor marker , 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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Twenty to eighty-year-old.
- •ASA class I-III.
- •Patients undergoing elective craniotomy for primary ovarian tumors under general anesthesia.
排除标准
- •Severe mental disorder
- •Poor liver function
- •Pregnant or lactating women
- •Morbid obesity
- •Have a history of allergy to any drug used in this study
- •Non-primary ovarian cancer surgery
- •Undergoing ovarian cancer pathological section surgery
- •Patients with incomplete medical records
- •Combined with other surgeries, emergency surgeries
- •Concomitant patients with other non-ovarian cancer therapy
- •Patients receiving palliative treatment after ovarian cancer surgery
- •During the maintenance period of anesthesia, propofol or sevoflurane should not be used as anesthetic drugs
- •Intraoperative combined use of multiple anesthetics (such as ketamine, dexmedetomidine, other inhalation anesthetics)
- •Those diagnosed with benign tumors before and after surgery
- •Patients with metastases to the ovary
研究组 & 干预措施
Sevoflurane group
The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3).
干预措施: Sevoflurane/Ultane (Drug)
Propofol group
The propofol group was both induced and 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 1% (Drug)
结局指标
主要结局
progression-free survival
时间窗: 5 years
progression-free survival
次要结局
- 6-month overall survival(6 months)
- 1-year overall survival(1 year)
- 3-year overall survival(3 years)
- 5-year overall survival(5 years)
- Karnofsky performance score(5 years)
- postoperative complications(30 days)
