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

NCT05606692 | Recruiting Phase 4

• 1 other identifier: KMUHIRB-F(II)-20220157
• Study Type: interventional
• Target: 416
• Locations: 1 country
• Sites: 1

Brief Summary

Ⅶ. Study procedures (summary)

1. 1.Written informed consent must be obtained before any study specific procedures are undertaken.
2. 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.

Conditions

Ovarian Cancer

Keywords

Primary Ovarian Cancer; Propofol; Sevoflurane; Survival

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  progression-free survival

  5 years

Secondary Outcomes (6)

• 6-month overall survival

  6 months

• 1-year overall survival

  1 year

• 3-year overall survival

  3 years

• 5-year overall survival

  5 years

• Karnofsky performance score

  5 years

Study Arms (2)

Sevoflurane group

ACTIVE COMPARATOR

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

Drug: Sevoflurane/Ultane

Propofol group

EXPERIMENTAL

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.

Drug: Propofol 1%

Interventions

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.

Also known as: ANESVAN INJECTION 10MG/ML (PROPOFOL) "CHI SHENG"

Propofol group

Sevoflurane/Ultane DRUG

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

Also known as: Sevoflurane/ Ultane 250mL/Bot

Sevoflurane group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead
• Tri-Service General Hospital: collaborator

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Propofol; Sevoflurane

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Zhi-Fu Wu

  Kaohsiung Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhi-Fu Wu, MD

CONTACT

07-3121101; aneswu@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 7, 2022
• Study Start: November 23, 2022
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: May 30, 2023

Record last verified: 2022-10

Locations

TW (1)