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Influences of Propofol and Sevoflurane Anesthesia in Brain Tumor (anesthetics)

Primary Purpose

Brain Tumor

Status
Recruiting
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Propofol
Sevoflurane
Sponsored by
Kaohsiung Medical University Chung-Ho Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Tumor focused on measuring Primary brain tumor, Propofol, Sevoflurane, Survival

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Propofol Group

Sevoflurane group

Arm Description

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The presence of disease progression
cancer recurrence after the surgery
Karnofsky performance status score
to access patients' functional impairment
Postoperative complications within 30 days
according to Clavien-Dindo classification

Full Information

First Posted
October 18, 2021
Last Updated
December 15, 2022
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Collaborators
Tri-Service General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05141877
Brief Title
Influences of Propofol and Sevoflurane Anesthesia in Brain Tumor
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 18, 2022 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
November 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Collaborators
Tri-Service General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor
Keywords
Primary brain tumor, Propofol, Sevoflurane, Survival

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
706 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Propofol Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Sevoflurane group
Arm Type
Experimental
Arm Description
The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3).
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
propofol anesthesia
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
inhalation anesthesia
Intervention Description
The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3).
Primary Outcome Measure Information:
Title
Overall survival
Description
6-month overall survival
Time Frame
6-month
Title
Overall survival
Description
1-year overall survival
Time Frame
1-year
Title
Overall survival
Description
3-year overall survival
Time Frame
3-year
Secondary Outcome Measure Information:
Title
The presence of disease progression
Description
cancer recurrence after the surgery
Time Frame
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"
Title
Karnofsky performance status score
Description
to access patients' functional impairment
Time Frame
Baseline (before the day of surgery)
Title
Postoperative complications within 30 days
Description
according to Clavien-Dindo classification
Time Frame
The period from the day of surgery until postoperative 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhi-Fu Wu, MD
Phone
07-3121101
Ext
7035
Email
aneswu@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhi-Fu Wu
Organizational Affiliation
Kaohsiung Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhi-Fu Wu

12. IPD Sharing Statement

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Influences of Propofol and Sevoflurane Anesthesia in Brain Tumor

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