NCT05606692 Influences of Propofol and Sevoflurane Anesthesia in Ovarian Cancer (Anesthetics)
| NCT ID | NCT05606692 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Kaohsiung Medical University Chung-Ho Memorial Hospital |
| Condition | Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 416 participants |
| Start Date | 2022-11-23 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 416 participants in total. It began in 2022-11-23 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Zhi-Fu Wu
PRINCIPAL INVESTIGATOR
Kaohsiung Medical University
Frequently Asked Questions
Who can join the NCT05606692 clinical trial?
This trial is open to female participants only, aged 20 Years or older, up to 80 Years, studying Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05606692 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05606692 currently recruiting?
Yes, NCT05606692 is actively recruiting participants. Contact the research team at aneswu@gmail.com for enrollment information.
Where is the NCT05606692 trial being conducted?
This trial is being conducted at Kaohsiung City, Taiwan.
Who is sponsoring the NCT05606692 clinical trial?
NCT05606692 is sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital. The principal investigator is Zhi-Fu Wu at Kaohsiung Medical University. The trial plans to enroll 416 participants.
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