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BIS-MA: Anesthetic Depth Effects Upon Immune Competent Cells

Sponsor
Heidelberg University (Other)
Overall Status
Completed
CT.gov ID
NCT02794896
Collaborator
(none)
16
Enrollment
1
Location
2
Arms
48
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: High dose propofol, fentanyl and sevoflurane
  • Drug: Low dose propofol, fentanyl and sevoflurane
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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 :
Mar 1, 2009
Actual Primary Completion Date :
Mar 1, 2012
Actual Study Completion Date :
Mar 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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
Deep Anesthesia
Other Names:
  • 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
    Shallow Anesthesia
    Other Names:
  • BIS above 45

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Depression of lymphocyte proliferation by CD expression pattern in SASPA-Test as given in a percentage from before anesthesia [70-90 min]

      before and following anesthesia period over 60 min

    Secondary Outcome Measures

    1. Reduction of phagocytosis activity as a percentage of base line (prior to anesthesia) [70-90 min]

      before and following anesthesia period over 60 min

    2. Protein expression pattern of monocytes by proteomics analysis and mass spectrometry [70-90 min]

      before and following anesthesia period over 60 min

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Medicine of Mannheim, Dept. Anesthesiology and Critical Care Medicine Mannheim Germany 68163

    Sponsors and Collaborators

    • Heidelberg University

    Investigators

    • Principal Investigator: Thomas Frietsch, MD, PhD, University of Mannheim

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Thomas Frietsch, Associate Professor of the Dept. of Anesthesiology and Critical Care Medicine, Universitätsmedizin Mannheim
    ClinicalTrials.gov Identifier:
    NCT02794896
    Other Study ID Numbers:
    • Anesthetic depth-MA
    First Posted:
    Jun 9, 2016
    Last Update Posted:
    May 24, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Inert Gas Narcosis
    Fentanyl
    Propofol
    Sevoflurane

    Study Results

    No Results Posted as of May 24, 2022