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

Primary Purpose

Immunotoxicity, Anesthesia, Inert Gas Narcosis

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
High dose propofol, fentanyl and sevoflurane
Low dose propofol, fentanyl and sevoflurane
Sponsored by
Heidelberg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immunotoxicity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Medicine of Mannheim, Dept. Anesthesiology and Critical Care Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Deep Anesthesia

Shallow Anesthesia

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Reduction of phagocytosis activity as a percentage of base line (prior to anesthesia)
before and following anesthesia period over 60 min
Protein expression pattern of monocytes by proteomics analysis and mass spectrometry
before and following anesthesia period over 60 min

Full Information

First Posted
May 12, 2016
Last Updated
May 17, 2022
Sponsor
Heidelberg University
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1. Study Identification

Unique Protocol Identification Number
NCT02794896
Brief Title
Anesthetic Depth Effects Upon Immune Competent Cells
Acronym
BIS-MA
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 Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heidelberg University

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immunotoxicity, Anesthesia, Inert Gas Narcosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Deep Anesthesia
Arm Type
Experimental
Arm Description
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.
Arm Title
Shallow Anesthesia
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
High dose propofol, fentanyl and sevoflurane
Other Intervention Name(s)
BIS lower than or equal to 45
Intervention Description
Deep Anesthesia
Intervention Type
Drug
Intervention Name(s)
Low dose propofol, fentanyl and sevoflurane
Other Intervention Name(s)
BIS above 45
Intervention Description
Shallow Anesthesia
Primary Outcome Measure Information:
Title
Depression of lymphocyte proliferation by CD expression pattern in SASPA-Test as given in a percentage from before anesthesia
Description
before and following anesthesia period over 60 min
Time Frame
70-90 min
Secondary Outcome Measure Information:
Title
Reduction of phagocytosis activity as a percentage of base line (prior to anesthesia)
Description
before and following anesthesia period over 60 min
Time Frame
70-90 min
Title
Protein expression pattern of monocytes by proteomics analysis and mass spectrometry
Description
before and following anesthesia period over 60 min
Time Frame
70-90 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Frietsch, MD, PhD
Organizational Affiliation
University of Mannheim
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medicine of Mannheim, Dept. Anesthesiology and Critical Care Medicine
City
Mannheim
ZIP/Postal Code
68163
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
per request

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Anesthetic Depth Effects Upon Immune Competent Cells

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