Clinical trial NCT05926336: The Effects of Using Different Anesthetics on the Prognosis of Primary Tumors and Its Mechanism of Action
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Lung Cancer
Brain Tumor
Liver Cancer
Ovarian Cancer
Keywords: Propofol
Sevoflurane
Survival
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 1316
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* eighteen to eighty-year-old
* ASA class I-III patients
* Elective surgery for brain, liver, lungs, ovarian cancer under general anesthesia

Exclusion Criteria:

* Severe mental disorder, poor liver function, pregnant or lactating women, morbidly obese, allergy to any of the drugs used in this study, recurrent tumor or repeat surgery, biopsy cases, incomplete outcome-data, palliative treatment after surgery, simultaneous treatment of other malignancies, emergency surgery, presence of other malignant tumors, combined propofol and inhalation anesthesia or other anesthetics, such as ketamine or dexmedetomidine, diagnosed as benign brain, liver, lungs, ovarian cancer、cell carcinoma or other metastatic.

Primary outcomes:
measure: Overall survival
timeFrame: From the date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
measure: The presence of disease progression
timeFrame: From the date of surgery until the date of first documented progression (recurrence or metastasis),assessed up to 36 months
Secondary outcomes:
measure: Postoperative complications
timeFrame: The period from the day of surgery to postoperative 30 days
measure: Karnofsky performance status score
timeFrame: postoperation 6 months, postoperation 12 months,postoperation 36 months.
measure: Length of hospital stays
timeFrame: from the day of surgery to dischage, assessed up to 30 days
Other outcomes:
measure: time of operation and anesthesia
timeFrame: from start to end of the procedure
measure: blood loss
timeFrame: from start to end of the procedure
measure: volume of blood transfusion
timeFrame: from start to end of the procedure
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
affiliation: Kaohsiung Medical University
name: Zhi-Fu Wu
role: PRINCIPAL_INVESTIGATOR
References: