Effects of Anesthesia on Immunity in Cancer

May 31, 2019 updated by: Efremov Sergey, Meshalkin Research Institute of Pathology of Circulation

Immunomodulatory Effects of Volatile and Total Intravenous Anesthesia for Patients With Renal Cancer

The aim of the study is a comparative study of the cellular immunity response of patients operated on for kidney cancer under total intravenous and inhalational anesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The severity of perioperative immunosuppression is directly proportional to the degree of surgical stress. A series of experimental and clinical studies indicate a different effect of certain types of anesthesia on immunity. It is believed that surgical stress itself opens an opportunity for the recurrence of oncological diseases precisely due to the immunosuppressive effect. The aim of present pilot clinical study is to test a hypothesis that total intravenous anesthesia as superior to inhalational anesthesia in term of its effects on cell immunity among patients with kidney cancer.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Novosibirsk, Russian Federation
        • State Research Institute of Circulation Pathology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Surgery for renal cancer
  • Signed informed concent

Exclusion Criteria:

  • Propofol or sevoflurane intolerance
  • Contraindications for epidural anesthesia
  • Renal failure
  • Hepatic failure
  • Congestive heart failure
  • Previous hemotherapy
  • Hematological diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: total intravenous anesthesia
Patients, scheduled for nephrectomy for kidney cancer will receive neuraxial epidural block and propofol for perioperative anesthesia
Drug: Propofol
Propofol will be used for anesthesia during surgery
Procedure: Epidural block
Epidural catheterization Th9-Th10, ropivacaine for perioperative analgesia
ACTIVE_COMPARATOR: Volatile anesthesia
Patients, scheduled for nephrectomy for kidney cancer will receive neuraxial epidural block and sevoflurane for perioperative anesthesia
Procedure: Epidural block
Epidural catheterization Th9-Th10, ropivacaine for perioperative analgesia
Drug: Sevoflurane
Sevoflurane will be used for anesthesia during surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CD 16
Time Frame: postoperative day 1
NK cells expression of CD16 receptor
postoperative day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CD45
Time Frame: Baseline, end of surgery, postoperative days 1, 3-4, 7
CD45 expression on lymphocytes measured with flow cytometry
Baseline, end of surgery, postoperative days 1, 3-4, 7
CD3
Time Frame: Baseline, end of surgery, postoperative days 1, 3-4, 7
CD3 expression on lymphocytes measured with flow cytometry
Baseline, end of surgery, postoperative days 1, 3-4, 7
CD19
Time Frame: Baseline, end of surgery, postoperative days 1, 3-4, 7
CD19 expression on lymphocytes measured with flow cytometry
Baseline, end of surgery, postoperative days 1, 3-4, 7
CD4
Time Frame: Baseline, end of surgery, postoperative days 1, 3-4, 7
CD4 expression on lymphocytes measured with flow cytometry
Baseline, end of surgery, postoperative days 1, 3-4, 7
CD8
Time Frame: Baseline, end of surgery, postoperative days 1, 3-4, 7
CD8 expression on lymphocytes measured with flow cytometry
Baseline, end of surgery, postoperative days 1, 3-4, 7
CD16
Time Frame: Baseline, end of surgery, postoperative days 1, 3-4, 7
CD16 expression on lymphocytes measured with flow cytometry
Baseline, end of surgery, postoperative days 1, 3-4, 7
CD25
Time Frame: Baseline, end of surgery, postoperative days 1, 3-4, 7
CD25 expression on lymphocytes measured with flow cytometry
Baseline, end of surgery, postoperative days 1, 3-4, 7
HLA-DR
Time Frame: Baseline, end of surgery, postoperative days 1, 3-4, 7
HLA-DR expression on lymphocytes measured with flow cytometry
Baseline, end of surgery, postoperative days 1, 3-4, 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 14, 2018

Primary Completion (ACTUAL)

April 1, 2019

Study Completion (ACTUAL)

May 20, 2019

Study Registration Dates

First Submitted

April 13, 2018

First Submitted That Met QC Criteria

April 20, 2018

First Posted (ACTUAL)

May 2, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 3, 2019

Last Update Submitted That Met QC Criteria

May 31, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Onko1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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