Ovarian Cancer
Conditions
Keywords
Primary Ovarian Cancer, Propofol, Sevoflurane, Survival
Brief summary
Ⅶ. Study procedures (summary) 1. 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.
Detailed description
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.
Interventions
DRUGPropofol 1%
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.
DRUGSevoflurane/Ultane
The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3).
Sponsors
Tri-Service General Hospital
Kaohsiung Medical University Chung-Ho Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Twenty to eighty-year-old. 2. ASA class I-III. 3. Patients undergoing elective craniotomy for primary ovarian tumors under general anesthesia.
Exclusion criteria
1. Severe mental disorder 2. Poor liver function 3. Pregnant or lactating women 4. Morbid obesity 5. Have a history of allergy to any drug used in this study 6. Non-primary ovarian cancer surgery 7. Undergoing ovarian cancer pathological section surgery 8. Patients with incomplete medical records 9. Combined with other surgeries, emergency surgeries 10. Concomitant patients with other non-ovarian cancer therapy 11. Patients receiving palliative treatment after ovarian cancer surgery 12. During the maintenance period of anesthesia, propofol or sevoflurane should not be used as anesthetic drugs 13. Intraoperative combined use of multiple anesthetics (such as ketamine, dexmedetomidine, other inhalation anesthetics) 14. Those diagnosed with benign tumors before and after surgery 15. Patients with metastases to the ovary
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progression-free survival | 5 years | progression-free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1-year overall survival | 1 year | 1-year overall survival |
| 3-year overall survival | 3 years | 3-year overall survival |
| 6-month overall survival | 6 months | 6-month overall survival |
| Karnofsky performance score | 5 years | Karnofsky performance score, from 100 to 0, where 100 is perfect health and 0 is death. The lower the Karnofsky performance score, the worse the likelihood of survival. |
| postoperative complications | 30 days | postoperative complications within 30 days (according Clavien-Dindo classification) |
| 5-year overall survival | 5 years | 5-year overall survival |
Countries
Taiwan
Contacts
Primary ContactZhi-Fu Wu, MD
Outcome results
None listed