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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05331911
• Other study ID #: KMUHIRB-F(I)-20220034
• Status: Recruiting
• Phase: Phase 4
• Start date: April 26, 2022
• Est. completion date: March 31, 2027

Study information

• Verified date: March 2022
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: Guan-Yu Chen, M.D.
• Phone: 07-3121101
• Email: kindtaco[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Propofol
total intravenous anesthesia with propofol for the partial hepatectomy of hepatocellular carcinoma.
• Sevoflurane
The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3 MAC).

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung

Sponsors (2)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital	Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	time of operation and anesthesia	record the time the operation and anesthesia	time of the total procedure
Other	blood loss and blood transfusion	record the blood loss (ml) and volume of blood transfusion (ml)	during the operation of partial hepatectomy
Primary	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"
Primary	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	Postoperative complications	Clavien-Dindo classification, and other postoperative complications	The period from the day of surgery to postoperative 30 days
Secondary	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
Secondary	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