Impact of Propofol-Based Total Intravenous Anesthesia Versus Anesthesia With Sevoflurane on Long-term Outcomes With Patients Undergoing Elective Excision of Primary Liver Tumors

Официальное название

Impact of Propofol-Based Total Intravenous Anesthesia Versus Anesthesia With Sevoflurane

Обзор

This is a two-arm, parallel-group randomized clinical trial. Routine perioperative care would be performed in volunteers with primary Hepatocellular carcinoma. The study will enroll approximately 500 volunteers to compare the progression-free or overall survival in patients undergoing elective partial hepatectomy for primary liver tumors between propofol and sevoflurane for the maintenance of anesthesia.

Подробное описание

Before the scheduled procedure, the patients are randomly assigned into peopofol group or groups (1:1) according to the randomization generated by the computer. Both groups were induced with propofol 1\~2.5 mg/kg propofol. The propofol group was maintained at an effect-site concentration of 2.0-4.0 mcg/mL by a target-controlled infusion system. The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3 MAC). 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 score and functional capacity, the postoperative complications within 30 days (according Clavien-Dindo classification), American Society of Anesthesiologists physical status scores, 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
  total intravenous anesthesia with propofol for the partial hepatectomy of hepatocellular carcinoma.
• Препарат Sevoflurane
  The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3 MAC).

Первичные конечные точки

• Overall survival [Срок оценки: From the date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months"]
• The presence of disease progression [Срок оценки: From the date of surgery until the date of first documented progression (recurrence or metastasis),assessed up to 36 months]

Вторичные конечные точки (3)

• Postoperative complications [Срок оценки: The period from the day of surgery to postoperative 30 days]
• Karnofsky performance status score [Срок оценки: Karnofsky performance score(from 0 (dead) to 100(normal no complication)) before surgery (baseline data) , postoperation 7 days, postoperation 3 months, postoperation 6 months, postoperation 12 months]
• Length of hospital stays [Срок оценки: from the day of surgery to dischage, assessed up to 30 days]

Критерии участия

Критерии включения

• Twenty to eighty-year-old.
• ASA class I-III.
• Patients undergoing partial hepatectomy for hepatocellular carcinoma under general anesthesia.

Критерии исключения

• Severe mental disorder
• Pregnant or lactating women
• Morbidly obese
• Allergy to any of the drugs used in this study
• Recurrent tumor or repeat surgery
• Biopsy cases
• Incomplete data collection before the surgery
• Palliative treatment after surgery
• simultaneous treatment of other malignancies
• Combined propofol and inhalation anesthesia or other anesthetics, such as ketamine or dexmedetomidine
• Diagnosed as benign liver tumor
• Emergency surgery

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: NCT05331911 · KMUHIRB-F(I)-20220034

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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