Effects of Anesthesia on Immunity in Cancer

Phase 4

Completed

• Conditions: Renal Cancer; Surgery
• Interventions: Drug: Propofol; Drug: Sevoflurane; Procedure: Epidural block

• Registration Number: NCT03514550
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-04-13
• Study First Submitted QC: 2018-04-20
• Study First Posted: 2018-05-02
• Study Start: 2018-05-14
• Primary Completion: 2019-04-01
• Status Verified: 2019-05
• Study Completion: 2019-05-20
• Last Update Submitted: 2019-05-31
• Last Update Posted: 2019-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Volatile anesthesia	Epidural block	Patients, scheduled for nephrectomy for kidney cancer will receive neuraxial epidural block and sevoflurane for perioperative anesthesia
total intravenous anesthesia	Epidural block	Patients, scheduled for nephrectomy for kidney cancer will receive neuraxial epidural block and propofol for perioperative anesthesia
total intravenous anesthesia	Propofol	Patients, scheduled for nephrectomy for kidney cancer will receive neuraxial epidural block and propofol for perioperative anesthesia
Volatile anesthesia	Sevoflurane	Patients, scheduled for nephrectomy for kidney cancer will receive neuraxial epidural block and sevoflurane for perioperative anesthesia

Primary Outcome Measures

Name	Time	Method
CD 16	postoperative day 1	NK cells expression of CD16 receptor

Secondary Outcome Measures

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

Trial Locations

Locations (1)

State Research Institute of Circulation Pathology; 🇷🇺 Novosibirsk, Russian Federation