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

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Drug Propofol
  total intravenous anesthesia with propofol for the partial hepatectomy of hepatocellular carcinoma.
• Drug Sevoflurane
  The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3 MAC).

Primary outcome measures

• Overall survival [Time frame: 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 [Time frame: From the date of surgery until the date of first documented progression (recurrence or metastasis),assessed up to 36 months]

Secondary outcome measures (3)

• Postoperative complications [Time frame: The period from the day of surgery to postoperative 30 days]
• Karnofsky performance status score [Time frame: 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 [Time frame: from the day of surgery to dischage, assessed up to 30 days]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Taiwan · 1 center

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

Identifiers

NCT: NCT05331911 · KMUHIRB-F(I)-20220034

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗