Anesthetic Depth Effects Upon Immune Competent Cells

Anesthesia Clinical Trial

— BIS-MA  

Official title:

Hypnotic Depth Reduces Lymphocyte Proliferation to Natural Killer Cells, B-cells, Memory T-cells, Depresses Intracellular Oxidative Burst and Changes Protein Expression Pattern of Monocytes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02794896
• Other study ID #: Anesthetic depth-MA
• Status: Completed
• Phase: N/A
• Start date: March 2009
• Est. completion date: March 2013

Study information

• Verified date: May 2022
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Anesthesia depth affects the proliferation of lymphocytes to NK-cells and memory T-cells effect and the phagocytosis activity of macrophages in healthy patients. ASA 1-3 subjects undergoing extended shoulder surgery under continuous regional anesthesia randomly were assigned to a deep or a shallow anesthesia level (BIS <35 or >55) for more than an hour. Immune response is measured by lymphocyte proliferation as well as neutrophil and monocyte phagocytosis activity.

Description:

Blood samples were taken under minimal stress prior to anesthesia induction (T0), recovery (T1) and 12 weeks following hospital discharge (T2) from the respective anesthesia depth level. Bispectral index monitoring (BIS) was performed from the awake state to complete recovery in all subjects.

Hemoglobin concentration, leukocyte and lymphocyte counts were determined by routine automated laboratory techniques. Lymphocyte proliferation was analyzed by SASPA flow cytometry analysis. In brief, 100 µl EDTA blood were stirred with 10 µl FITC and PE marked antibody mixture containing CD3, CD4, CD8, CD 16, CD45, CD28, CD27, CD 56.

Monocyte and neutrophil phagocytosis activity was measured separately in macrophages of fresh heparinized whole blood using flow cytometric test kits.

Proteomics of monocytes was done synchronously.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 2013
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• enrolment for longer shoulder surgery

• consent for the standard anesthesia form in combination with the interscalene plexus block

• ASA Status 1-3

Exclusion Criteria:

• sedative premedication

• severe immune deficiency (diabetes, steroid or antihistamine medication, cancer, chemotherapy,

• status post transplantation, drug and alcohol abuse),

• recent surgery (1 month) or blood transfusion

Related Conditions & MeSH terms

• Anesthesia
• Immunotoxicity
• Inert Gas Narcosis

Intervention

Drug:
• High dose propofol, fentanyl and sevoflurane
Deep Anesthesia
• Low dose propofol, fentanyl and sevoflurane
Shallow Anesthesia

Locations

Country	Name	City	State
Germany	University Medicine of Mannheim, Dept. Anesthesiology and Critical Care Medicine	Mannheim

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression of lymphocyte proliferation by CD expression pattern in SASPA-Test as given in a percentage from before anesthesia	before and following anesthesia period over 60 min	70-90 min
Secondary	Reduction of phagocytosis activity as a percentage of base line (prior to anesthesia)	before and following anesthesia period over 60 min	70-90 min
Secondary	Protein expression pattern of monocytes by proteomics analysis and mass spectrometry	before and following anesthesia period over 60 min	70-90 min