Influences of Propofol and Sevoflurane Anesthesia in Brain Tumor

Brain Tumor Clinical Trial

— anesthetics  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05141877
• Other study ID #: KMUHIRB-F(II)-20210167
• Status: Recruiting
• Phase: Phase 4
• Start date: February 18, 2022
• Est. completion date: November 30, 2025

Study information

• Verified date: October 2023
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: Zhi-Fu Wu, MD
• Phone: 07-3121101
• Email: aneswu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 706
• Est. completion date: November 30, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor

Intervention

Drug:
• 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.
• Sevoflurane
The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3).

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung

Sponsors (2)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital	Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	6-month overall survival	6-month
Primary	Overall survival	1-year overall survival	1-year
Primary	Overall survival	3-year overall survival	3-year
Secondary	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"
Secondary	Karnofsky performance status score	to access patients' functional impairment	Baseline (before the day of surgery)
Secondary	Postoperative complications within 30 days	according to Clavien-Dindo classification	The period from the day of surgery until postoperative 30 days