Skip to content

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02794896
Acronym
BIS-MA
Enrollment
16
Registered
2016-06-09
Start date
2009-03-31
Completion date
2013-03-31
Last updated
2022-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Immunotoxicity, Inert Gas Narcosis

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 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.

Interventions

DRUGHigh dose propofol, fentanyl and sevoflurane

Deep Anesthesia

DRUGLow dose propofol, fentanyl and sevoflurane

Shallow Anesthesia

Sponsors

Heidelberg University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Depression of lymphocyte proliferation by CD expression pattern in SASPA-Test as given in a percentage from before anesthesia70-90 minbefore and following anesthesia period over 60 min

Secondary

MeasureTime frameDescription
Reduction of phagocytosis activity as a percentage of base line (prior to anesthesia)70-90 minbefore and following anesthesia period over 60 min
Protein expression pattern of monocytes by proteomics analysis and mass spectrometry70-90 minbefore and following anesthesia period over 60 min

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026