Influences of Propofol and Sevoflurane Anesthesia in Brain Tumor

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of Propofol-Based Total Intravenous Anesthesia Versus Anesthesia With Sevoflurane on Long-term Outcomes With Patients Undergoing Elective Craniotomy for Primary Brain Tumors

Conditions
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Brain Tumor

Intervention / Treatment
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* Drug: Propofol
* Drug: Sevoflurane


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propofol Group<br>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. | Drug: Propofol<br>* 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.<br>* Other names: propofol anesthesia;|
| Experimental: Sevoflurane group<br>The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3). | Drug: Sevoflurane<br>* The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3).<br>* Other names: inhalation anesthesia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | 6-month overall survival | 6-month | 
| Overall survival | 1-year overall survival | 1-year | 
| Overall survival | 3-year overall survival | 3-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The presence of disease progression | cancer recurrence after the surgery | 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 | 
| Karnofsky performance status score | to access patients' functional impairment | Baseline (before the day of surgery) | 
| Postoperative complications within 30 days | according to Clavien-Dindo classification | The period from the day of surgery until postoperative 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary brain tumor, Propofol, Sevoflurane, Survival