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Recruiting NCT05606692

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

Conditions: Ovarian Cancer

Sex: Female
Ages: 20 Years – 80 Years
Phase: PHASE4
Enrollment: 416
Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Location: Taiwan

Summary

Ⅶ. Study procedures (summary)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.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 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 disorderPoor liver functionPregnant or lactating womenMorbid obesityHave a history of allergy to any drug used in this studyNon-primary ovarian cancer surgeryUndergoing ovarian cancer pathological section surgeryPatients with incomplete medical recordsCombined with other surgeries, emergency surgeriesConcomitant patients with other non-ovarian cancer therapyPatients receiving palliative treatment after ovarian cancer surgeryDuring the maintenance period of anesthesia, propofol or sevoflurane should not be used as anesthetic drugsIntraoperative combined use of multiple anesthetics (such as ketamine, dexmedetomidine, other inhalation anesthetics)Those diagnosed with benign tumors before and after surgeryPatients with metastases to the ovary

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05606692). StuddyBuddy aggregates publicly available trial information.