Actively Recruiting

Phase 4
Age: 20Years - 80Years
FEMALE
NCT05606692

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

Led by Kaohsiung Medical University Chung-Ho Memorial Hospital · Updated on 2023-05-30

416

Participants Needed

1

Research Sites

253 weeks

Total Duration

On this page

Sponsors

K

Kaohsiung Medical University Chung-Ho Memorial Hospital

Lead Sponsor

T

Tri-Service General Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 20Years - 80Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged between 20 and 80 years
  • ASA physical status class I to III
  • Undergoing elective surgery for primary ovarian tumors under general anesthesia
Not Eligible

You will not qualify if you...

  • Severe mental disorders
  • Poor liver function
  • Pregnant or lactating women
  • Morbid obesity
  • History of allergy to any study drugs
  • Surgery for non-primary ovarian cancer
  • Undergoing ovarian cancer pathological section surgery
  • Incomplete medical records
  • Combined or emergency surgeries
  • Receiving other non-ovarian cancer therapies
  • Receiving palliative treatment after ovarian cancer surgery
  • Anesthesia maintenance without propofol or sevoflurane
  • Use of multiple anesthetics during surgery (e.g., ketamine, dexmedetomidine, other inhalation anesthetics)
  • Diagnosed with benign tumors before or after surgery
  • Patients with ovarian metastases

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Trial Site Locations

Total: 1 location

1

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Actively Recruiting

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Research Team

Z

Zhi-Fu Wu, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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