To Compare the Effects of Intraoperative Use of Intravenous Anesthetics Propofol and Inhaled Anesthetics Sevoflurane on the Prognosis of Patients Undergoing Surgery for Primary Brain, Liver, Lung, and Ovarian Cancer Tumors and the Investigation of Its Mechanism of Action

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

1. Eligible participants were assessed prior to anesthesia. After the patient is admitted to the hospital, the subject's consent form is explained, and the consent form must be signed before the operation. 2. This is a two-arm, parallel-group randomized clinical trial.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
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 80
Healthy Volunteers: f
View:

• eighteen to eighty-year-old

• ASA class I-III patients

• Elective surgery for brain, liver, lungs, ovarian cancer under general anesthesia

Locations
Other Locations
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
Contact Information
Primary
Zhi-Fu Wu, MD
aneswu@gmail.com
07-3121101
Time Frame
Start Date: 2023-05-23
Estimated Completion Date: 2026-07
Participants
Target number of participants: 1316
Treatments
Experimental: Sevoflurane
The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3).
Experimental: Propofol
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.
Sponsors
Leads: Kaohsiung Medical University Chung-Ho Memorial Hospital

This content was sourced from clinicaltrials.gov