Clinical trial NCT05141877: Influences of Propofol and Sevoflurane Anesthesia in Brain Tumor
Official title: Impact of Propofol-Based Total Intravenous Anesthesia Versus Anesthesia With Sevoflurane on Long-term Outcomes With Patients Undergoing Elective Craniotomy for Primary Brain Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Brain Tumor
Keywords: Primary brain tumor
Propofol
Sevoflurane
Survival
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Tri-Service General Hospital
First posted: 2021-12-02
Enrollment: 706
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: 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). 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), American Society of Anesthesiologists(ASA) physical status scores, 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.

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, 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 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:

1. Twenty to eighty-year-old.
2. ASA class I-III.
3. Patients undergoing elective craniotomy for primary brain tumors under general anesthesia.

Exclusion Criteria:

1. Severe mental disorder
2. Poor liver function
3. Pregnant or lactating women
4. Morbidly obese
5. Allergy to any of the drugs used in this study
6. Recurrent tumor or repeat surgery
7. Biopsy cases
8. Incomplete outcome-data
9. Palliative treatment after surgery
10. simultaneous treatment of other malignancies
11. Emergency surgery
12. Presence of other malignant tumors
13. Combined propofol and inhalation anesthesia or other anesthetics, such as ketamine or dexmedetomidine
14. Diagnosed as benign brain tumor
15. cerebellum tumor and pituitary gland tumor.

Primary outcomes:
measure: Overall survival
timeFrame: 6-month
measure: Overall survival
timeFrame: 1-year
measure: Overall survival
timeFrame: 3-year
Secondary outcomes:
measure: The presence of disease progression
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: Karnofsky performance status score
timeFrame: Baseline (before the day of surgery)
measure: Postoperative complications within 30 days
timeFrame: The period from the day of surgery until postoperative 30 days
Other outcomes:
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: