Effects of Anesthesia on Immunity in Cancer

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03514550
• Other study ID #: Onko1
• Status: Completed
• Phase: Phase 4
• Start date: May 14, 2018
• Est. completion date: May 20, 2019

Study information

• Verified date: May 2019
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 20, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Neoplasms
• Renal Cancer
• Surgery

Intervention

Drug:
• Propofol
Propofol will be used for anesthesia during surgery
• Sevoflurane
Sevoflurane will be used for anesthesia during surgery

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

Locations

Country	Name	City	State
Russian Federation	State Research Institute of Circulation Pathology	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CD 16	NK cells expression of CD16 receptor	postoperative day 1
Secondary	CD45	CD45 expression on lymphocytes measured with flow cytometry	Baseline, end of surgery, postoperative days 1, 3-4, 7
Secondary	CD3	CD3 expression on lymphocytes measured with flow cytometry	Baseline, end of surgery, postoperative days 1, 3-4, 7
Secondary	CD19	CD19 expression on lymphocytes measured with flow cytometry	Baseline, end of surgery, postoperative days 1, 3-4, 7
Secondary	CD4	CD4 expression on lymphocytes measured with flow cytometry	Baseline, end of surgery, postoperative days 1, 3-4, 7
Secondary	CD8	CD8 expression on lymphocytes measured with flow cytometry	Baseline, end of surgery, postoperative days 1, 3-4, 7
Secondary	CD16	CD16 expression on lymphocytes measured with flow cytometry	Baseline, end of surgery, postoperative days 1, 3-4, 7
Secondary	CD25	CD25 expression on lymphocytes measured with flow cytometry	Baseline, end of surgery, postoperative days 1, 3-4, 7
Secondary	HLA-DR	HLA-DR expression on lymphocytes measured with flow cytometry	Baseline, end of surgery, postoperative days 1, 3-4, 7