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Influences of Propofol and Sevoflurane Anesthesia in Ovarian Cancer (Anesthetics) (anesthetics)

Primary Purpose

Ovarian Cancer

Status
Recruiting
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Propofol 1%
Sevoflurane/Ultane
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 Ovarian Cancer focused on measuring Primary Ovarian Cancer, Propofol, Sevoflurane, Survival

Eligibility Criteria

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

Inclusion Criteria: Twenty to eighty-year-old. ASA class I-III. Patients undergoing elective craniotomy for primary ovarian tumors under general anesthesia. Exclusion Criteria: Severe mental disorder Poor liver function Pregnant or lactating women Morbid obesity Have a history of allergy to any drug used in this study Non-primary ovarian cancer surgery Undergoing ovarian cancer pathological section surgery Patients with incomplete medical records Combined with other surgeries, emergency surgeries Concomitant patients with other non-ovarian cancer therapy Patients receiving palliative treatment after ovarian cancer surgery During the maintenance period of anesthesia, propofol or sevoflurane should not be used as anesthetic drugs Intraoperative combined use of multiple anesthetics (such as ketamine, dexmedetomidine, other inhalation anesthetics) Those diagnosed with benign tumors before and after surgery Patients with metastases to the ovary

Sites / Locations

  • Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Sevoflurane group

Propofol group

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

progression-free survival
progression-free survival

Secondary Outcome Measures

6-month overall survival
6-month overall survival
1-year overall survival
1-year overall survival
3-year overall survival
3-year overall survival
5-year overall survival
5-year overall survival
Karnofsky performance 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.
postoperative complications
postoperative complications within 30 days (according Clavien-Dindo classification)

Full Information

First Posted
October 31, 2022
Last Updated
May 26, 2023
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Collaborators
Tri-Service General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05606692
Brief Title
Influences of Propofol and Sevoflurane Anesthesia in Ovarian Cancer (Anesthetics)
Acronym
anesthetics
Official Title
Impact of Propofol-Based Total Intravenous Anesthesia Versus Anesthesia With Sevoflurane on Long-term Outcomes With Patients Undergoing Elective Surgery for Primary Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 23, 2022 (Actual)
Primary Completion Date
September 30, 2026 (Anticipated)
Study Completion Date
September 30, 2027 (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
Ⅶ. Study procedures (summary) Written informed consent must be obtained before any study specific procedures are undertaken. Qualified participants were identified at the pre-anesthesia evaluation clinic or ward. The informed consents are obtained from the patient in the ward at night before the operation. The process of the experiment (brief describe) 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
Ovarian Cancer
Keywords
Primary Ovarian Cancer, Propofol, Sevoflurane, Survival

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
416 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sevoflurane group
Arm Type
Active Comparator
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 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.
Intervention Type
Drug
Intervention Name(s)
Propofol 1%
Other Intervention Name(s)
ANESVAN INJECTION 10MG/ML (PROPOFOL) "CHI SHENG"
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/Ultane
Other Intervention Name(s)
Sevoflurane/ Ultane 250mL/Bot
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
progression-free survival
Description
progression-free survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
6-month overall survival
Description
6-month overall survival
Time Frame
6 months
Title
1-year overall survival
Description
1-year overall survival
Time Frame
1 year
Title
3-year overall survival
Description
3-year overall survival
Time Frame
3 years
Title
5-year overall survival
Description
5-year overall survival
Time Frame
5 years
Title
Karnofsky performance 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
5 years
Title
postoperative complications
Description
postoperative complications within 30 days (according Clavien-Dindo classification)
Time Frame
30 days

10. Eligibility

Sex
Female
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 ovarian tumors under general anesthesia. Exclusion Criteria: Severe mental disorder Poor liver function Pregnant or lactating women Morbid obesity Have a history of allergy to any drug used in this study Non-primary ovarian cancer surgery Undergoing ovarian cancer pathological section surgery Patients with incomplete medical records Combined with other surgeries, emergency surgeries Concomitant patients with other non-ovarian cancer therapy Patients receiving palliative treatment after ovarian cancer surgery During the maintenance period of anesthesia, propofol or sevoflurane should not be used as anesthetic drugs Intraoperative combined use of multiple anesthetics (such as ketamine, dexmedetomidine, other inhalation anesthetics) Those diagnosed with benign tumors before and after surgery Patients with metastases to the ovary
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 Ovarian Cancer (Anesthetics)

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