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The Effects of Using Different Anesthetics on the Prognosis of Primary Tumors and Its Mechanism of Action

Primary Purpose

Lung Cancer, Brain Tumor, Liver Cancer

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 Lung Cancer focused on measuring Propofol, Sevoflurane, Survival

Eligibility Criteria

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

Inclusion Criteria: eighteen to eighty-year-old ASA class I-III patients Elective surgery for brain, liver, lungs, ovarian cancer 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, liver, lungs, ovarian cancer、cell carcinoma or other metastatic.

Sites / Locations

  • Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sevoflurane

Propofol

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Overall survival
6-month overall survival, 1-year overall survival, and 3-year overall survival
The presence of disease progression
From the date of surgery until the date of first documented progression (recurrence or metastasis) or date of death from any cause, assessed up to 36 months

Secondary Outcome Measures

Postoperative complications
Clavien-Dindo classification, and other postoperative complications
Karnofsky performance status score
Karnofsky performance score, from 100 to 0, where 100 is perfect health and 0 is death. The lower the Karnofsky performance score, the worse the likelihood of survival.
Length of hospital stays
the length of stays in general ward and ICU

Full Information

First Posted
May 26, 2023
Last Updated
September 25, 2023
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05926336
Brief Title
The Effects of Using Different Anesthetics on the Prognosis of Primary Tumors and Its Mechanism of Action
Official Title
To Compare the Effects of Intraoperative Use of Intravenous Anesthetics Propofol and Inhaled Anesthetics Sevoflurane on the Prognosis of Patients Undergoing Surgery for Primary Brain, Liver, Lung, and Ovarian Cancer Tumors and the Investigation of Its Mechanism of Action
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2023 (Actual)
Primary Completion Date
July 2026 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial 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
Eligible participants were assessed prior to anesthesia. After the patient is admitted to the hospital, the subject's consent form is explained, and the consent form must be signed before the operation. This is a two-arm, parallel-group randomized clinical trial.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). 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 marker ,tumor size, intraoperative blood loss/transfusion, duration of surgery, duration of anesthesia, total opioid (remifentanil/fentanyl) use, postoperative radiation therapy, postoperative chemotherapy, postoperative concurrent chemoradiotherapy, the presence of disease progression, and 6-month, 1-year, 3-year and 5-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, 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 scoress, tumor marker , 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
Lung Cancer, Brain Tumor, Liver Cancer, Ovarian Cancer
Keywords
Propofol, Sevoflurane, Survival

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1316 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sevoflurane
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).
Arm Title
Propofol
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.
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
total intravenous 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 MAC)
Primary Outcome Measure Information:
Title
Overall survival
Description
6-month overall survival, 1-year overall survival, and 3-year overall survival
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
The presence of disease progression
Description
From the date of surgery until the date of first documented progression (recurrence or metastasis) or date of death from any cause, assessed up to 36 months
Time Frame
From the date of surgery until the date of first documented progression (recurrence or metastasis),assessed up to 36 months
Secondary Outcome Measure Information:
Title
Postoperative complications
Description
Clavien-Dindo classification, and other postoperative complications
Time Frame
The period from the day of surgery to postoperative 30 days
Title
Karnofsky performance status score
Description
Karnofsky performance score, from 100 to 0, where 100 is perfect health and 0 is death. The lower the Karnofsky performance score, the worse the likelihood of survival.
Time Frame
postoperation 6 months, postoperation 12 months,postoperation 36 months.
Title
Length of hospital stays
Description
the length of stays in general ward and ICU
Time Frame
from the day of surgery to dischage, assessed up to 30 days
Other Pre-specified Outcome Measures:
Title
time of operation and anesthesia
Description
record the time the opeartion and anesthesia
Time Frame
from start to end of the procedure
Title
blood loss
Description
record the blood loss (ml)
Time Frame
from start to end of the procedure
Title
volume of blood transfusion
Description
volume of blood transfusion (ml)
Time Frame
from start to end of the procedure

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: eighteen to eighty-year-old ASA class I-III patients Elective surgery for brain, liver, lungs, ovarian cancer 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, liver, lungs, ovarian cancer、cell carcinoma or other metastatic.
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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The Effects of Using Different Anesthetics on the Prognosis of Primary Tumors and Its Mechanism of Action

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