Clinical Trials Directory

Trials / Completed

CompletedNCT02794896

Anesthetic Depth Effects Upon Immune Competent Cells

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
16 (actual)
Sponsor
Heidelberg University · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
DRUGHigh dose propofol, fentanyl and sevofluraneDeep Anesthesia
DRUGLow dose propofol, fentanyl and sevofluraneShallow Anesthesia

Timeline

Start date
2009-03-01
Primary completion
2012-03-01
Completion
2013-03-01
First posted
2016-06-09
Last updated
2022-05-24

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT02794896. Inclusion in this directory is not an endorsement.