NCT05606692: anesthetics

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

Recruiting now Phase 4 Last updated 30 May 2023

What this trial tests

Phase 4 trial testing Propofol 1% in Ovarian Cancer in 416 participants. Currently enrolling.

Timeline

23 November 2022

Primary endpoint
30 September 2026

30 September 2027

Quick facts

Lead sponsor	Kaohsiung Medical University Chung-Ho Memorial Hospital
Phase	Phase 4
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	416
Start date	23 November 2022
Primary completion	30 September 2026
Estimated completion	30 September 2027
Sites	1 location across Taiwan

Drugs / interventions tested

• Propofol 1% — full drug profile →
• Sevoflurane/Ultane — full drug profile →

Conditions studied

• Ovarian Cancer — all drugs for Ovarian Cancer →

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Who can join

Adults 20 to 80, female only, with Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.