Anesthetic Depth Effects Upon Immune Competent Cells (BIS-MA)
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|ClinicalTrials.gov Identifier: NCT02794896|
Recruitment Status : Completed
First Posted : June 9, 2016
Last Update Posted : October 28, 2016
|Condition or disease||Intervention/treatment||Phase|
|Immunotoxicity Anesthesia Inert Gas Narcosis||Drug: High dose propofol, fentanyl and sevoflurane Drug: Low dose propofol, fentanyl and sevoflurane||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||March 2013|
Experimental: Deep Anesthesia
Standard anesthesia with fentanyl, propofol for shoulder surgery together with a interscalene plexus block was performed. The anesthesiologist only was informed about the group allocation by the study director and tried to control best for maintenance on target anesthesia level BIS 45 (group 1, deep anesthesia). Anesthesia depth was measured by BIS monitors (BIS Vista, Aspect) for every minute and the minutes below or equal to a BIS level of 45 were counted.
Drug: High dose propofol, fentanyl and sevoflurane
Other Name: BIS lower than or equal to 45
Experimental: Shallow Anesthesia
Standard anesthesia with fentanyl, propofol for shoulder surgery together with a inter scalene plexus block was performed. The anesthesiologist only was informed about the group allocation by the study director and tried to control best for maintenance on target anesthesia level BIS ≥ 55 (group 2, shallow anesthesia). Anesthesia depth as measured by BIS monitors (BIS Vista, Aspect) for every minute and the minutes above a BIS level of 45 were counted.
Drug: Low dose propofol, fentanyl and sevoflurane
Other Name: BIS above 45
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02794896
|University Medicine of Mannheim, Dept. Anesthesiology and Critical Care Medicine|
|Mannheim, Germany, 68163|
|Principal Investigator:||Thomas Frietsch, MD, PhD||University of Mannheim|