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

Официальное название

Impact of Propofol-Based Total Intravenous Anesthesia Versus Anesthesia With Sevoflurane on Long-term Outcomes With Patients Undergoing Elective Surgery for Primary Ovarian Cancer

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Propofol 1%
  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.
• Препарат Sevoflurane/Ultane
  The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3).

Первичные конечные точки

• progression-free survival [Срок оценки: 5 years]

Вторичные конечные точки (6)

• 6-month overall survival [Срок оценки: 6 months]
• 1-year overall survival [Срок оценки: 1 year]
• 3-year overall survival [Срок оценки: 3 years]
• 5-year overall survival [Срок оценки: 5 years]
• Karnofsky performance score [Срок оценки: 5 years]
• postoperative complications [Срок оценки: 30 days]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City

Идентификаторы

NCT: NCT05606692 · KMUHIRB-F(II)-20220157

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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