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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Drug: Propofol; Drug: Sevoflurane

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 Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Guan-Yu Chen, M.D.; Phone Number: 7035 07-3121101; Email: kindtaco@gmail.com

Study Locations

• Taiwan
  • Kaohsiung, Taiwan
    • Recruiting
    • Kaohsiung Medical University Chung-Ho Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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: total intravenous anesthesia
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	6-month overall survival, 1-year overall survival, and 3-year 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"
The presence of disease progression	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"	From the date of surgery until the date of first documented progression (recurrence or metastasis),assessed up to 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	Clavien-Dindo classification, and other postoperative complications	The period from the day of surgery to postoperative 30 days
Karnofsky performance status score	to access patients' functional impairment	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
Length of hospital stays	the length of stays in general ward and ICU	from the day of surgery to dischage, assessed up to 30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
time of operation and anesthesia	record the time the operation and anesthesia	time of the total procedure
blood loss and blood transfusion	record the blood loss (ml) and volume of blood transfusion (ml)	during the operation of partial hepatectomy

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Collaborators: Tri-Service General Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 26, 2022
• Primary Completion (ANTICIPATED): December 31, 2026
• Study Completion (ANTICIPATED): March 31, 2027

Study Registration Dates

• First Submitted: March 29, 2022
• First Submitted That Met QC Criteria: April 15, 2022
• First Posted (ACTUAL): April 18, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma, Hepatocellular; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Hypnotics and Sedatives; Anesthetics, Inhalation; Propofol; Sevoflurane
• Other Study ID Numbers: KMUHIRB-F(I)-20220034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: depends the various challenges in this study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No