Clinical trial NCT05606692: Influences of Propofol and Sevoflurane Anesthesia in Ovarian Cancer (Anesthetics)
Official title: Impact of Propofol-Based Total Intravenous Anesthesia Versus Anesthesia With Sevoflurane on Long-term Outcomes With Patients Undergoing Elective Surgery for Primary Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Ovarian Cancer
Keywords: Primary Ovarian Cancer
Propofol
Sevoflurane
Survival
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Tri-Service General Hospital
First posted: 2022-11-07
Enrollment: 416
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: progression-free survival
timeFrame: 5 years
Secondary outcomes:
measure: 6-month overall survival
timeFrame: 6 months
measure: 1-year overall survival
timeFrame: 1 year
measure: 3-year overall survival
timeFrame: 3 years
measure: 5-year overall survival
timeFrame: 5 years
measure: Karnofsky performance score
timeFrame: 5 years
measure: postoperative complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
affiliation: Kaohsiung Medical University
name: Zhi-Fu Wu
role: PRINCIPAL_INVESTIGATOR
References: