Anesthesia Clinical Trial
— BIS-MAOfficial 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
Verified date | May 2022 |
Source | Heidelberg University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Germany | University Medicine of Mannheim, Dept. Anesthesiology and Critical Care Medicine | Mannheim |
Lead Sponsor | Collaborator |
---|---|
Heidelberg University |
Germany,
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 |
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