Clinical trial NCT05331911: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hepatocellular Carcinoma
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Tri-Service General Hospital
First posted: 2022-04-18
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: 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"
measure: The presence of disease progression
timeFrame: From the date of surgery until the date of first documented progression (recurrence or metastasis),assessed up to 36 months
Secondary outcomes:
measure: Postoperative complications
timeFrame: The period from the day of surgery to postoperative 30 days
measure: Karnofsky performance status score
timeFrame: 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
measure: Length of hospital stays
timeFrame: from the day of surgery to dischage, assessed up to 30 days
Other outcomes:
measure: time of operation and anesthesia
timeFrame: time of the total procedure
measure: blood loss and blood transfusion
timeFrame: during the operation of partial hepatectomy
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
References: