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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02794896
Other study ID # Anesthetic depth-MA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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