Influences of Propofol and Sevoflurane Anesthesia in Brain Tumor

Phase 4

Recruiting

• Conditions: Brain Tumor
• Interventions: Drug: Sevoflurane; Drug: Propofol

• Registration Number: NCT05141877
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

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 Timeline

• Study First Submitted: 2021-10-18
• Study First Submitted QC: 2021-12-01
• Study First Posted: 2021-12-02
• Study Start: 2022-02-18
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-29
• Last Update Posted: 2023-10-31
• Primary Completion: 2024-11-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 706

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sevoflurane group	Sevoflurane	The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3).
Propofol Group	Propofol	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.

Primary Outcome Measures

Name	Time	Method
Overall survival	3-year	3-year overall survival

Secondary Outcome Measures

Name	Time	Method
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
Postoperative complications within 30 days	The period from the day of surgery until postoperative 30 days	according to Clavien-Dindo classification
Karnofsky performance status score	Baseline (before the day of surgery)	to access patients' functional impairment

Trial Locations

Locations (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan