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Effects of Anesthesia on Immunity in Cancer

Primary Purpose

Surgery, Renal Cancer

Status
Completed
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
Propofol
Sevoflurane
Epidural block
Sponsored by
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • State Research Institute of Circulation Pathology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

total intravenous anesthesia

Volatile anesthesia

Arm Description

Patients, scheduled for nephrectomy for kidney cancer will receive neuraxial epidural block and propofol for perioperative anesthesia

Patients, scheduled for nephrectomy for kidney cancer will receive neuraxial epidural block and sevoflurane for perioperative anesthesia

Outcomes

Primary Outcome Measures

CD 16
NK cells expression of CD16 receptor

Secondary Outcome Measures

CD45
CD45 expression on lymphocytes measured with flow cytometry
CD3
CD3 expression on lymphocytes measured with flow cytometry
CD19
CD19 expression on lymphocytes measured with flow cytometry
CD4
CD4 expression on lymphocytes measured with flow cytometry
CD8
CD8 expression on lymphocytes measured with flow cytometry
CD16
CD16 expression on lymphocytes measured with flow cytometry
CD25
CD25 expression on lymphocytes measured with flow cytometry
HLA-DR
HLA-DR expression on lymphocytes measured with flow cytometry

Full Information

First Posted
April 13, 2018
Last Updated
May 31, 2019
Sponsor
Meshalkin Research Institute of Pathology of Circulation
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1. Study Identification

Unique Protocol Identification Number
NCT03514550
Brief Title
Effects of Anesthesia on Immunity in Cancer
Official Title
Immunomodulatory Effects of Volatile and Total Intravenous Anesthesia for Patients With Renal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
May 14, 2018 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
May 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery, Renal Cancer

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
total intravenous anesthesia
Arm Type
Experimental
Arm Description
Patients, scheduled for nephrectomy for kidney cancer will receive neuraxial epidural block and propofol for perioperative anesthesia
Arm Title
Volatile anesthesia
Arm Type
Active Comparator
Arm Description
Patients, scheduled for nephrectomy for kidney cancer will receive neuraxial epidural block and sevoflurane for perioperative anesthesia
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
Propofol will be used for anesthesia during surgery
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
Sevoflurane will be used for anesthesia during surgery
Intervention Type
Procedure
Intervention Name(s)
Epidural block
Intervention Description
Epidural catheterization Th9-Th10, ropivacaine for perioperative analgesia
Primary Outcome Measure Information:
Title
CD 16
Description
NK cells expression of CD16 receptor
Time Frame
postoperative day 1
Secondary Outcome Measure Information:
Title
CD45
Description
CD45 expression on lymphocytes measured with flow cytometry
Time Frame
Baseline, end of surgery, postoperative days 1, 3-4, 7
Title
CD3
Description
CD3 expression on lymphocytes measured with flow cytometry
Time Frame
Baseline, end of surgery, postoperative days 1, 3-4, 7
Title
CD19
Description
CD19 expression on lymphocytes measured with flow cytometry
Time Frame
Baseline, end of surgery, postoperative days 1, 3-4, 7
Title
CD4
Description
CD4 expression on lymphocytes measured with flow cytometry
Time Frame
Baseline, end of surgery, postoperative days 1, 3-4, 7
Title
CD8
Description
CD8 expression on lymphocytes measured with flow cytometry
Time Frame
Baseline, end of surgery, postoperative days 1, 3-4, 7
Title
CD16
Description
CD16 expression on lymphocytes measured with flow cytometry
Time Frame
Baseline, end of surgery, postoperative days 1, 3-4, 7
Title
CD25
Description
CD25 expression on lymphocytes measured with flow cytometry
Time Frame
Baseline, end of surgery, postoperative days 1, 3-4, 7
Title
HLA-DR
Description
HLA-DR expression on lymphocytes measured with flow cytometry
Time Frame
Baseline, end of surgery, postoperative days 1, 3-4, 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
State Research Institute of Circulation Pathology
City
Novosibirsk
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effects of Anesthesia on Immunity in Cancer

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