Impact of Propofol-Based Total Intravenous Anesthesia Versus Anesthesia With Sevoflurane on Long-term Outcomes With Patients Undergoing Elective Craniotomy for Primary Brain Tumors
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Enrollment
- 706
- Locations
- 1
- Primary Endpoint
- Overall survival
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Twenty to eighty-year-old.
- •ASA class I-III.
- •Patients undergoing elective craniotomy for primary brain tumors 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 tumor
- •cerebellum tumor and pituitary gland tumor.
Arms & Interventions
Propofol Group
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.
Intervention: Propofol (Drug)
Sevoflurane group
The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3).
Intervention: Sevoflurane (Drug)
Outcomes
Primary Outcomes
Overall survival
Time Frame: 3-year
3-year overall survival
Secondary Outcomes
- 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")
- Postoperative complications within 30 days(The period from the day of surgery until postoperative 30 days)
- Karnofsky performance status score(Baseline (before the day of surgery))