Effects of Anesthesia on Immunity in Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Surgery, Renal Cancer

Intervention / Treatment
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* Drug: Propofol
* Drug: Sevoflurane
* Procedure: Epidural block


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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