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Effects of Anesthesia on Immunity in Cancer

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ClinicalTrials.gov Identifier: NCT03514550
Recruitment Status : Completed
First Posted : May 2, 2018
Last Update Posted : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
Efremov Sergey, Meshalkin Research Institute of Pathology of Circulation

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.

Condition or disease Intervention/treatment Phase
Surgery Renal Cancer Drug: Propofol Drug: Sevoflurane Procedure: Epidural block Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Immunomodulatory Effects of Volatile and Total Intravenous Anesthesia for Patients With Renal Cancer
Actual Study Start Date : May 14, 2018
Actual Primary Completion Date : April 1, 2019
Actual Study Completion Date : May 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer

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
Drug: Sevoflurane
Sevoflurane will be used for anesthesia during surgery

Procedure: Epidural block
Epidural catheterization Th9-Th10, ropivacaine for perioperative analgesia




Primary Outcome Measures :
  1. CD 16 [ Time Frame: postoperative day 1 ]
    NK cells expression of CD16 receptor


Secondary Outcome Measures :
  1. CD45 [ Time Frame: Baseline, end of surgery, postoperative days 1, 3-4, 7 ]
    CD45 expression on lymphocytes measured with flow cytometry

  2. CD3 [ Time Frame: Baseline, end of surgery, postoperative days 1, 3-4, 7 ]
    CD3 expression on lymphocytes measured with flow cytometry

  3. CD19 [ Time Frame: Baseline, end of surgery, postoperative days 1, 3-4, 7 ]
    CD19 expression on lymphocytes measured with flow cytometry

  4. CD4 [ Time Frame: Baseline, end of surgery, postoperative days 1, 3-4, 7 ]
    CD4 expression on lymphocytes measured with flow cytometry

  5. CD8 [ Time Frame: Baseline, end of surgery, postoperative days 1, 3-4, 7 ]
    CD8 expression on lymphocytes measured with flow cytometry

  6. CD16 [ Time Frame: Baseline, end of surgery, postoperative days 1, 3-4, 7 ]
    CD16 expression on lymphocytes measured with flow cytometry

  7. CD25 [ Time Frame: Baseline, end of surgery, postoperative days 1, 3-4, 7 ]
    CD25 expression on lymphocytes measured with flow cytometry

  8. HLA-DR [ Time Frame: Baseline, end of surgery, postoperative days 1, 3-4, 7 ]
    HLA-DR expression on lymphocytes measured with flow cytometry



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514550


Locations
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Russian Federation
State Research Institute of Circulation Pathology
Novosibirsk, Russian Federation
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation

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Responsible Party: Efremov Sergey, Principal investigator, Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT03514550     History of Changes
Other Study ID Numbers: Onko1
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Anesthetics
Propofol
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Anesthetics, Inhalation