Influences of Propofol and Sevoflurane Anesthesia in Ovarian Cancer (Anesthetics)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Propofol 1%, Sevoflurane/Ultane.
- Who it may be relevant to
- Registry conditions: Ovarian Cancer. Basic parameters: 20 years — 80 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Propofol-Based Total Intravenous Anesthesia Versus Anesthesia With Sevoflurane on Long-term Outcomes With Patients Undergoing Elective Surgery for Primary Ovarian Cancer
Overview
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.
Detailed description
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, 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 scoress, tumor marker , tumor size, intraoperative blood loss/transfusion, duration of surgery, duration of anesthesia, total opioid (remifentanil/ fentanyl/ propofol) use, postoperative radiation therapy, postoperative chemotherapy, postoperative concurrent chemoradiotherapy, the presence of disease progression, and 6-month, 1-year, and 3-year overall survival and Karnofsky performance status score were recorded.
Interventions
- Drug Propofol 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. - Drug Sevoflurane/Ultane
The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3).
Primary outcome measures
- progression-free survival [Time frame: 5 years]
Secondary outcome measures (6)
- 6-month overall survival [Time frame: 6 months]
- 1-year overall survival [Time frame: 1 year]
- 3-year overall survival [Time frame: 3 years]
- 5-year overall survival [Time frame: 5 years]
- Karnofsky performance score [Time frame: 5 years]
- postoperative complications [Time frame: 30 days]
Eligibility criteria
Inclusion criteria
- Twenty to eighty-year-old.
- ASA class I-III.
- Patients undergoing elective craniotomy for primary ovarian tumors under general anesthesia.
Exclusion criteria
- Severe mental disorder
- Poor liver function
- Pregnant or lactating women
- Morbid obesity
- Have a history of allergy to any drug used in this study
- Non-primary ovarian cancer surgery
- Undergoing ovarian cancer pathological section surgery
- Patients with incomplete medical records
- Combined with other surgeries, emergency surgeries
- 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
- Intraoperative combined use of multiple anesthetics (such as ketamine, dexmedetomidine, other inhalation anesthetics)
- Those diagnosed with benign tumors before and after surgery
- Patients with metastases to the ovary
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City
Identifiers
NCT: NCT05606692 · KMUHIRB-F(II)-20220157