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NCT Number: NCT03514550

Effects of Anesthesia on Immunity in 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.

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Key information

Conditions

Surgery Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Renal Cancer Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

State Research Institute of Circulation Pathology

Novosibirsk, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

Propofol will be used for anesthesia during surgery

Sevoflurane

Drug

Sevoflurane will be used for anesthesia during surgery

Epidural block

Procedure

Epidural catheterization Th9-Th10, ropivacaine for perioperative analgesia

Primary outcomes

  1. CD 16

    Time frame: postoperative day 1

    NK cells expression of CD16 receptor

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Meshalkin Research Institute of Pathology of Circulation

Network

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 2, 2018
Registry last updated
Jun 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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