Brain Tumor
Conditions
Keywords
Primary brain tumor, Propofol, Sevoflurane, Survival
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.
Interventions
DRUGPropofol
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.
DRUGSevoflurane
The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3).
Sponsors
Tri-Service General Hospital
Kaohsiung Medical University Chung-Ho Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 6-month | 6-month overall survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The presence of disease progression | 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 | cancer recurrence after the surgery |
| Karnofsky performance status score | Baseline (before the day of surgery) | to access patients' functional impairment |
| Postoperative complications within 30 days | The period from the day of surgery until postoperative 30 days | according to Clavien-Dindo classification |
Countries
Taiwan
Contacts
Primary ContactZhi-Fu Wu, MD
Outcome results
None listed