RecruitingPhase 4NCT05606692

Influences of Propofol and Sevoflurane Anesthesia in Ovarian Cancer (Anesthetics)

Impact of Propofol-Based Total Intravenous Anesthesia Versus Anesthesia With Sevoflurane on Long-term Outcomes With Patients Undergoing Elective Surgery for Primary Ovarian Cancer


Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Enrollment

416 participants

Start Date

Nov 23, 2022

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 20 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study compares two common anesthesia drugs — propofol and sevoflurane — to see if one affects outcomes better than the other in patients undergoing surgery for primary ovarian cancer. **You may be eligible if...** - You are between 20 and 80 years old - You are in generally acceptable health for surgery (ASA class I–III) - You are scheduled for elective surgery for a primary ovarian tumor under general anesthesia **You may NOT be eligible if...** - You have severe mental health disorders or poor liver function - You are pregnant or breastfeeding - You have severe obesity - You have a known drug allergy to any of the anesthetics used - Your ovarian cancer has spread from another site (metastatic to ovary) - You are having emergency surgery or surgery for benign tumors Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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).


Locations(1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

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NCT05606692


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