Impact of Propofol-Based Total Intravenous Anesthesia Versus Anesthesia With Sevoflurane on Long-term Outcomes With Patients Undergoing Elective Excision of Primary Liver Tumors
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Propofol Group 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. |
Drug: Propofol
total intravenous anesthesia with propofol for the partial hepatectomy of hepatocellular carcinoma.
Other Names:
|
| Experimental: Sevoflurane group The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3 MAC). |
Drug: Sevoflurane
The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3 MAC).
|
Outcome Measures
Primary Outcome Measures
- Overall survival [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"]
6-month overall survival, 1-year overall survival, and 3-year overall survival
- The presence of disease progression [From the date of surgery until the date of first documented progression (recurrence or metastasis),assessed up to 36 months]
From the date of surgery until the date of first documented progression (recurrence or metastasis) or date of death from any cause, assessed up to 36 months"
Secondary Outcome Measures
- Postoperative complications [The period from the day of surgery to postoperative 30 days]
Clavien-Dindo classification, and other postoperative complications
- Karnofsky performance status score [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]
to access patients' functional impairment
- Length of hospital stays [from the day of surgery to dischage, assessed up to 30 days]
the length of stays in general ward and ICU
Other Outcome Measures
- time of operation and anesthesia [time of the total procedure]
record the time the operation and anesthesia
- blood loss and blood transfusion [during the operation of partial hepatectomy]
record the blood loss (ml) and volume of blood transfusion (ml)
Eligibility Criteria
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
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Biopsy cases
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Incomplete data collection before the surgery
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Palliative treatment after surgery
-
simultaneous treatment of other malignancies
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Combined propofol and inhalation anesthesia or other anesthetics, such as ketamine or dexmedetomidine
-
Diagnosed as benign liver tumor
-
Emergency surgery
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Tri-Service General Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KMUHIRB-F(I)-20220034