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

Study acronym: anesthetics
StatusRecruiting
PhasePhase 4
Started
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Record status
This record was last updated May 30, 2023 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Site contact updatedv4
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 2022 to Nov 23, 2022
    • Site details revised
    v3
  3. Minor Secondary endpoints revised (6)v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05606692
Lead Sponsor Kaohsiung Medical University Chung-Ho Memorial Hospital
Collaborators: Tri-Service General Hospital (TSGH)
Conditions
(from sponsor)
Ovarian Cancer
Related terms Ovarian Neoplasms
Enrollment 416 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov