Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Location status: Recruiting
NCT Number: NCT05331911
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.
Interested in participating?
Request Info20 year–80 year
All sexes
Interventional
Phase 4
Kaohsiung City, Taiwan
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
total intravenous anesthesia with propofol for the partial hepatectomy of hepatocellular carcinoma.
Other names: total intravenous anesthesia
The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3 MAC).
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"
6-month overall survival, 1-year overall survival, and 3-year overall survival
Time frame: 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"
Time frame: The period from the day of surgery to postoperative 30 days
Clavien-Dindo classification, and other postoperative complications
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
to access patients' functional impairment
Time frame: from the day of surgery to dischage, assessed up to 30 days
the length of stays in general ward and ICU
Time frame: time of the total procedure
record the time the operation and anesthesia
Time frame: during the operation of partial hepatectomy
record the blood loss (ml) and volume of blood transfusion (ml)
Contact information is provided by the study sponsor or research team.
Kaohsiung Medical University Chung-Ho Memorial Hospital
Other
Impact of Propofol-Based Total Intravenous Anesthesia Versus Anesthesia With Sevoflurane
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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