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Anesthetic Depth Effects Upon Immune Competent Cells (BIS-MA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02794896
Recruitment Status : Completed
First Posted : June 9, 2016
Last Update Posted : October 28, 2016
Sponsor:
Collaborator:
Heidelberg University
Information provided by (Responsible Party):
Prof. T. Frietsch, MD, MBA, Universitätsmedizin Mannheim

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
Immunotoxicity Anesthesia Inert Gas Narcosis Drug: High dose propofol, fentanyl and sevoflurane Drug: Low dose propofol, fentanyl and sevoflurane Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : March 2009
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


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 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
Shallow Anesthesia
Other Name: BIS above 45




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Protein expression pattern of monocytes by proteomics analysis and mass spectrometry [ Time Frame: 70-90 min ]
    before and following anesthesia period over 60 min



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Germany
University Medicine of Mannheim, Dept. Anesthesiology and Critical Care Medicine
Mannheim, Germany, 68163
Sponsors and Collaborators
Universitätsmedizin Mannheim
Heidelberg University
Investigators
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Principal Investigator: Thomas Frietsch, MD, PhD University of Mannheim
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Responsible Party: Prof. T. Frietsch, MD, MBA, 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: June 9, 2016    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: per request
Additional relevant MeSH terms:
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Inert Gas Narcosis
Occupational Diseases
Gas Poisoning
Poisoning
Chemically-Induced Disorders
Fentanyl
Propofol
Sevoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Platelet Aggregation Inhibitors
Anesthetics, Inhalation