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NCT Number: 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

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.

Recruiting

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

total intravenous anesthesia with propofol for the partial hepatectomy of hepatocellular carcinoma.

Other names: total intravenous anesthesia

Sevoflurane

Drug

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

Primary outcomes

  1. 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"

    6-month overall survival, 1-year overall survival, and 3-year overall survival

  2. 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

    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 outcomes

  1. Postoperative complications

    Time frame: The period from the day of surgery to postoperative 30 days

    Clavien-Dindo classification, and other postoperative complications

  2. 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

    to access patients' functional impairment

  3. Length of hospital stays

    Time frame: from the day of surgery to dischage, assessed up to 30 days

    the length of stays in general ward and ICU

Other outcomes

  1. time of operation and anesthesia

    Time frame: time of the total procedure

    record the time the operation and anesthesia

  2. blood loss and blood transfusion

    Time frame: during the operation of partial hepatectomy

    record the blood loss (ml) and volume of blood transfusion (ml)

Study contacts

Contact information is provided by the study sponsor or research team.

Guan-Yu Chen, M.D.

CONTACT

[email protected]

07-3121101 ext. 7035

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Collaborators

  • Tri-Service General Hospital (TSGH)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Apr 18, 2022
Registry last updated
Nov 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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