anesthetics: Influences of Propofol and Sevoflurane Anesthesia in Brain Tumor

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05141877

Collaborator

(none)

706

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Tumor	Drug: Propofol Drug: Sevoflurane	Phase 4

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

Anticipated Enrollment :

706 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Nov 30, 2024

Anticipated Study Completion Date :

Nov 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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. Other Names: propofol anesthesia
Experimental: Sevoflurane group The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3).	Drug: Sevoflurane The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3). Other Names: inhalation anesthesia

Arm

Intervention/Treatment

Experimental: 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.

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.

Other Names:

propofol anesthesia

Experimental: Sevoflurane group

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

Drug: Sevoflurane

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

Other Names:

inhalation anesthesia

Outcome Measures

Primary Outcome Measures

Overall survival [6-month]
6-month overall survival
Overall survival [1-year]
1-year overall survival
Overall survival [3-year]
3-year overall survival

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.