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NCT Number: NCT05606692

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

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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

20 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Location status: Recruiting

Location contact

Zhi-Fu Wu

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol 1%

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.

Other names: ANESVAN INJECTION 10MG/ML (PROPOFOL) "CHI SHENG"

Sevoflurane/Ultane

Drug

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

Other names: Sevoflurane/ Ultane 250mL/Bot

Primary outcomes

  1. progression-free survival

    Time frame: 5 years

    progression-free survival

Secondary outcomes

  1. 6-month overall survival

    Time frame: 6 months

    6-month overall survival

  2. 1-year overall survival

    Time frame: 1 year

    1-year overall survival

  3. 3-year overall survival

    Time frame: 3 years

    3-year overall survival

  4. 5-year overall survival

    Time frame: 5 years

    5-year overall survival

  5. Karnofsky performance score

    Time frame: 5 years

    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.

  6. postoperative complications

    Time frame: 30 days

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

Study contacts

Contact information is provided by the study sponsor or research team.

Zhi-Fu Wu, MD

CONTACT

[email protected]

07-3121101 ext. 7035

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Collaborators

  • Tri-Service General Hospital (TSGH)

Registry information

Official study 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

Acronym: anesthetics

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Nov 7, 2022
Registry last updated
May 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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