Effect of Propofol and Sevoflurane Anesthesia on HSP70 Expression in Tumor Cells

NCT06626711 | Active Not Recruiting Early Phase 1

• 1 other identifier: 23-25-00078
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if sevoflurane-based inhalational anesthesia (s-IA) and propofol-based total intravenous anesthesia (p-TVA) have different effects on HSP70 expression in different types of tumour cells. The main questions it aims to answer are:

• if p-TVA/s-IA increase or suppress HSP70 expression in tumor cells in comparison with a pre-anesthesia level;
• does this change in HSP70 expression cause any difference in vital characteristics of tumor cells, such as proliferation, apoptosis, colony formation and migration. Researchers will compare p-TVA with s-IA by ability of these types of anesthesia to change the HSP70 expression level and modulate HSP70-mediated effects in tumor cells. Participants will:
• be randomly allocated to p-TVA or s-IA groups;
• donate 12 ml of blood before anesthesia induction and 12 ml after 2 hours of anesthesia. The blood serum will be used to prepare cell medium. After exposure to this medium, cells from different tumor types will be investigated using cytological and molecular biological methods.

Conditions

Anesthesia; Cancer Recurrence; Cancer

Keywords

Cancer; Anesthesia; Sevoflurane; Propofol

Outcome Measures

Primary Outcomes (1)

• HSP70 expression in tumor cells in vitro

  Increased intracellular and extracellular HSP70 content in different types of tumor cells measured by SDS-PAGE/Western blotting and ELISA, respectively.

  24 hours after exposition with patients serum.

Secondary Outcomes (4)

• LDG cytotoxicity

  24 hours after exposition with patients serum.

• MTT test

  24 hours after exposition with patients serum.

• Wound healing test

  72 hours after exposition with patients serum.

• Cell colonies formation

  7 days after exposition with patients serum.

Study Arms (2)

Propofol-based total venous anesthesia group

EXPERIMENTAL

These patients will receive total venous anethesia where propofol is used as a hypnotic drug.

Drug: Propofol

Sevoflurane-based inhalational anesthesia group

EXPERIMENTAL

These patients will receive inhalational anethesia where sevoflurane is used as a hypnotic drug.

Drug: Sevoflurane

Interventions

Propofol DRUG

Propofol as a part of total venous anesthesia

Propofol-based total venous anesthesia group

Sevoflurane DRUG

Sevoflurane as a part of intravenous anesthesia

Sevoflurane-based inhalational anesthesia group

Eligibility Criteria

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

You may qualify if:

• Diagnosed malignant neoplasm
• Planned surgery for radical or palliative tumor resection
• Age over 18 years
• Signed informed consent

You may not qualify if:

• Diabetes mellitus type 2
• HIV, hepatitis B or C
• Emergency surgery
• Known or suspected allergy to studied drugs
• Other conditions when one of the types of anesthesia is more preferable (hemodynamic disorders, bronchial asthma etc)

Sponsors & Collaborators

• Saint Petersburg State University, Russia: lead
• Institute of Cytology of the Russian Academy of Sciences: collaborator
• The Russian Science Foundation: collaborator

Study Sites (1)

Saint Petersburg State University Hospital

Saint Petersburg, 1999034, Russia

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Propofol; Sevoflurane

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director for science, Saint-Petersburg state university hospital

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 4, 2024
• Study Start: October 10, 2024
• Primary Completion: November 30, 2025
• Study Completion: December 30, 2025
• Last Updated: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 01/10/2024 - 01/04/2025
• Access Criteria: By reasonable request.

Locations

RU (1)