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

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

NCT ID: NCT05606692

Condition: Ovarian Cancer

Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Propofol
Sevoflurane

Conditions: Keywords:
Primary Ovarian Cancer
Propofol
Sevoflurane
Survival

Study type: Interventional

Study phase: Phase 4

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Intervention:

Intervention type: Drug
Intervention name: Propofol 1%
Description: 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.
Arm group label: Propofol group

Other name: ANESVAN INJECTION 10MG/ML (PROPOFOL) "CHI SHENG"

Intervention type: Drug
Intervention name: Sevoflurane/Ultane
Description: The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3).
Arm group label: Sevoflurane group

Other name: Sevoflurane/ Ultane 250mL/Bot

Summary: 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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Twenty to eighty-year-old. 2. ASA class I-III. 3. Patients undergoing elective craniotomy for primary ovarian tumors under general anesthesia. Exclusion Criteria: 1. Severe mental disorder 2. Poor liver function 3. Pregnant or lactating women 4. Morbid obesity 5. Have a history of allergy to any drug used in this study 6. Non-primary ovarian cancer surgery 7. Undergoing ovarian cancer pathological section surgery 8. Patients with incomplete medical records 9. Combined with other surgeries, emergency surgeries 10. Concomitant patients with other non-ovarian cancer therapy 11. Patients receiving palliative treatment after ovarian cancer surgery 12. During the maintenance period of anesthesia, propofol or sevoflurane should not be used as anesthetic drugs 13. Intraoperative combined use of multiple anesthetics (such as ketamine, dexmedetomidine, other inhalation anesthetics) 14. Those diagnosed with benign tumors before and after surgery 15. Patients with metastases to the ovary

Gender: Female

Minimum age: 20 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Kaohsiung Medical University Chung-Ho Memorial Hospital

Address:
City: Kaohsiung
Country: Taiwan

Status: Recruiting

Contact:
Last name: Zhi-Fu Wu

Start date: November 23, 2022

Completion date: September 30, 2027

Lead sponsor:
Agency: Kaohsiung Medical University Chung-Ho Memorial Hospital
Agency class: Other

Collaborator:
Agency: Tri-Service General Hospital
Agency class: Other

Source: Kaohsiung Medical University Chung-Ho Memorial Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05606692