NCT05606692RecruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 30 May 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 416 (estimated)
- First submitted
- 31 Oct 2022
- Start date
- 23 Nov 2022
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Diseases
- Ovarian cancer
- NCT number
- NCT05606692
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 416
- From 23 Nov 2022 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant patients with other non-ovarian cancer therapy
- Patients receiving palliative treatment after ovarian cancer surgery
- During the maintenance period of anesthesia, propofol or sevoflurane should not be used as anesthetic drugs
- Those diagnosed with benign tumors before and after surgery
Other illness
- Severe mental disorder
- Have a history of allergy to any drug used in this study
- Non-primary ovarian cancer surgery
- Undergoing ovarian cancer pathological section surgery
Other
- Poor liver function
- Pregnant or lactating women
- Morbid obesity
- Patients with incomplete medical records
- Combined with other surgeries, emergency surgeries
- Intraoperative combined use of multiple anesthetics (such as ketamine, dexmedetomidine, other inhalation anesthetics)
- Patients with metastases to the ovary
Who the study is looking for
- Twenty to eighty-year-old.
- ASA class I-III.
- Patients undergoing elective craniotomy for primary ovarian tumors under general anesthesia.
Age in the registry: 20 years to 80 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kaohsiung Medical University Chung-Ho Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.