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Ovarian CancerPhase 4anestheticsNCT05606692

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

A Phase 4 study testing Propofol 1% and Sevoflurane/Ultane in people with Ovarian Cancer, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Ⅶ. Study procedures (summary) 1. 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. 2. Read more about this study

Who is it for?
Ages 20 to 80 years, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Propofol 1% and Sevoflurane/Ultane
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
416 participants
Where
1 siteTaiwan
Study dates
23 Nov 2022to 30 Sep 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zhi-Fu Wu, MD contact

07-3121101 ext. 7035

aneswu@gmail.com

Taiwan1 site, 1 recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City

    Zhi-Fu Wu

    Recruiting

Other trials in Taiwan

About this study

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

Ⅶ. Study procedures (summary)

  1. 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.
  2. 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.
Read the 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.

Conditions
Ovarian Cancer
Being tested
Propofol 1%, Sevoflurane/Ultane
Keywords
Primary Ovarian Cancer, Propofol, Sevoflurane, Survival
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Propofol 1%Drug

    Also called ANESVAN INJECTION 10MG/ML (PROPOFOL) "CHI SHENG"

    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.

  • Sevoflurane/UltaneDrug

    Also called Sevoflurane/ Ultane 250mL/Bot

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

Study groups in NCT05606692
Study groupRoleWhat they receive
Sevoflurane groupActive comparatorThe sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3).
Receives: Drug: Sevoflurane/Ultane
Propofol groupExperimentalThe 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.
Receives: Drug: Propofol 1%

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. progression-free survival

    progression-free survival

    Measured: 5 years

Secondary outcomes (6)

  1. 6-month overall survival

    6-month overall survival

    Measured: 6 months

  2. 1-year overall survival

    1-year overall survival

    Measured: 1 year

  3. 3-year overall survival

    3-year overall survival

    Measured: 3 years

  4. 5-year overall survival

    5-year overall survival

    Measured: 5 years

  5. 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.

    Measured: 5 years

  6. postoperative complications

    postoperative complications within 30 days (according Clavien-Dindo classification)

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2022
  2. Study start23 Nov 2022
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
416 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05606692
Sponsor's protocol ID
KMUHIRB-F(II)-20220157
Acronym
anesthetics
Status last verified
Oct 2022
First submitted
31 Oct 2022
Last updated
30 May 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Propofol 1% and Sevoflurane/Ultane in people with Ovarian Cancer, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhi-Fu Wu, MD (07-3121101 ext. 7035, aneswu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression-free survival (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05606692.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2023; AzTrials last refreshed its copy on 8 Nov 2026.

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