Clinical Trial: Anesthetic Depth Effects Upon Immune Competent Cells

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: Universitätsmedizin Mannheim

Current Primary Outcome: Depression of lymphocyte proliferation by CD expression pattern in SASPA-Test as given in a percentage from before anesthesia [ Time Frame: 70-90 min ]

before and following anesthesia period over 60 min


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Reduction of phagocytosis activity as a percentage of base line (prior to anesthesia) [ Time Frame: 70-90 min ]
    before and following anesthesia period over 60 min
  • Protein expression pattern of monocytes by proteomics analysis and mass spectrometry [ Time Frame: 70-90 min ]
    before and following anesthesia period over 60 min


Original Secondary Outcome:

  • Reduction of phagocytosis activity as given in a percentage from before anesthesia [ Time Frame: 70-90 min ]
    before and following anesthesia period over 60 min
  • Protein expression pattern of monocytes by proteomics analysis and mass spectrometry [ Time Frame: 70-90 min ]
    before and following anesthesia period over 60 min


Information By: Universitätsmedizin Mannheim

Dates:
Date Received: May 12, 2016
Date Started: March 2009
Date Completion:
Last Updated: October 26, 2016
Last Verified: October 2016