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

Kaohsiung Medical University

Status and phase: Enrolling; Phase 4

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Sevoflurane; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT05331911

KMUHIRB-F(I)-20220034

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Severe mental disorder
2. Pregnant or lactating women
3. Morbidly obese
4. Allergy to any of the drugs used in this study
5. Recurrent tumor or repeat surgery
6. Biopsy cases
7. Incomplete data collection before the surgery
8. Palliative treatment after surgery
9. simultaneous treatment of other malignancies
10. Combined propofol and inhalation anesthesia or other anesthetics, such as ketamine or dexmedetomidine
11. Diagnosed as benign liver tumor
12. Emergency surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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500 participants in 2 patient groups

Propofol Group

Experimental group

Description:

The propofol group was maintained at an effect-site concentration (Ce) of 2.0-4.0 mcg/mL by a target-controlled infusion (TCI) system.

Treatment:

Drug: Propofol

Sevoflurane group

Experimental group

Description:

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

Treatment:

Drug: Sevoflurane