Effect of Propofol and Desflurane on Nucleic Acid of Liver Circulating Tumor

NCT05502458 | Completed Phase 2 DMC

• 1 other identifier: 2020-09-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the effects of perioperative anesthetic drugs propofol and desflurane on circulating tumor nucleic acids (CK7, ELF3, EGFR and EphB4 mRNA) in the blood of patients with liver cancer, so as to provide scientific reference for clinical anesthesia in the perioperative treatment of tumor

Conditions

Hepatocellular Carcinoma; Desflurane Adverse Reaction; Propofol Adverse Reaction; Circulating Tumor Cells

Keywords

Desflurane; HCC; propofol; CTC

Outcome Measures

Primary Outcomes (1)

• The changes of circulating tumor nucleic acids (CK7, ELF3, EGFR and EphB4 mRNA) in peripheral blood of patients with hepatocellular carcinoma after perioperative treatment with propofol and desflurane

  Circulating tumor nucleic acid (CK7, ELF3, EGFR, and EphB4 mRNA) concentrations were determined by real-time RT-PCR in Applied Biosystems 7500 (Foster City, CA, USA) using SYBR® Premix Ex TaqTM II (Po, Otsu, Japan). Sequence of primers designed as previously described. Total mRNA was normalized to GAPDH and relative mRNA expression of the sample by calculating 2- δδCT, and differential expression of the sample was defined as upregulation when the cutoff value was set to 2x

  Immediately Before induction of anesthesia, Immediately before skinning after induction of anesthesia, during operation, PACU at the end of operation, and on the 7th day after operation

Study Arms (2)

propofol

ACTIVE COMPARATOR

propofol（50ml,1g）,Intravenous propofol infusion was slowly pushed until loss of consciousness, and anesthesia was maintained at 4-8 mg/kg/h

Drug: Propofol

desflurane

ACTIVE COMPARATOR

In the general anesthesia group with desflurane( 240ml), intravenous propofol infusion was slowly pushed until consciousness disappeared, and then anesthesia was maintained with 4-6% desflurane

Drug: Desflurane

Interventions

Desflurane DRUG

Propofol general anesthesia group (P group) : intravenous propofol infusion was slowly pushed until consciousness disappeared, and then anesthesia was maintained at 4-8 mg/kg/h. In the general anesthesia group with desflurane (group D), intravenous propofol infusion was slowly pushed until consciousness disappeared, and then anesthesia was maintained with 4-6% desflurane. The analgesic and muscle relaxant regimens were the same in both groups except for sedative drugs. All patients were treated with no medication before operation, and the operation was completed under endotracheal intubation and general anesthesia. The amount of propofol or desflurane was adjusted according to BIS or MAC values and hemodynamic changes during operation. Add 10mg of rocuronium every half hour. Vasoactive drugs can be used to maintain hemodynamic stability during the operation, and corresponding records should be made

Also known as: group D

desflurane

Propofol DRUG

Propofol general anesthesia group (P group) : intravenous propofol infusion was slowly pushed until consciousness disappeared, and then anesthesia was maintained at 4-8 mg/kg/h.

Also known as: group P

propofol

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range: 18 to 75
• ASA: I-III
• primary liver cancer (CNLC: Stage I-IIIA)
• undergoing elective hepatectomy

You may not qualify if:

• Patients with severe bradycardia (HR \< 55bpm)
• patients with severe arrhythmias or cardiac dysfunction (EF \< 35%)
• patients with severe respiratory lung disease
• patients with severe liver and kidney insufficiency epilepsy
• patients with severe hyperlipidemia
• patients with a history of malignant hyperthermia
• patients with propofol or desflurane allergy
• patients with history of preoperative chemoradiotherapy
• patients who were on immunosuppressive treatment
• patients with chronic opioid therapy declined to participate in the study

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer hospital

Hangzhou, Zhejiang, 310022, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Neoplastic Cells, Circulating

Interventions

Propofol

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: By statistical professionals using SAS software on the computer, according to the propofol group and halothane group the proportion of 1:1, to patients by ASA classification, disease category, coexist, the condition of the body after stratified according to stratified random methods such as random coding, in this study, each participant will be according to the center of the random number sequence into the propofol group and halothane group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Model Details: Propofol general anesthesia group (P group) : intravenous propofol infusion was slowly pushed until consciousness disappeared, and then anesthesia was maintained at 4-8 mg/kg/h. In the general anesthesia group with desflurane (group D), intravenous propofol infusion was slowly pushed until consciousness disappeared, and then anesthesia was maintained with 4-6% desflurane

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 16, 2022
• Study Start: December 1, 2020
• Primary Completion: August 8, 2022
• Study Completion: August 8, 2022
• Last Updated: August 16, 2022

Record last verified: 2022-08

Locations

CN (1)