Influences of Propofol and Sevoflurane Anesthesia in Brain Tumor

NCT05141877 | Unknown Phase 4

• 1 other identifier: KMUHIRB-F(II)-20210167
• Study Type: interventional
• Target: 706
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Tumor

Keywords

Primary brain tumor; Propofol; Sevoflurane; Survival

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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"

• Karnofsky performance status score

  Baseline (before the day of surgery)

• Postoperative complications within 30 days

  The period from the day of surgery until postoperative 30 days

Study Arms (2)

Propofol Group

EXPERIMENTAL

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

Sevoflurane group

EXPERIMENTAL

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

Drug: Sevoflurane

Interventions

Propofol DRUG

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.

Also known as: propofol anesthesia

Propofol Group

Sevoflurane DRUG

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

Also known as: inhalation anesthesia

Sevoflurane group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Twenty to eighty-year-old.
• ASA class I-III.
• Patients undergoing elective craniotomy for primary brain tumors under general anesthesia.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead
• Tri-Service General Hospital: collaborator

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Propofol; Sevoflurane; Anesthesia, Inhalation

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Anesthesia, General; Anesthesia; Anesthesia and Analgesia

Study Officials

• Zhi-Fu Wu

  Kaohsiung Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhi-Fu Wu, MD

CONTACT

07-3121101; aneswu@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: December 2, 2021
• Study Start: February 18, 2022
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2025
• Last Updated: October 31, 2023

Record last verified: 2023-10

Locations

TW (1)