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Completed

NCT Number: NCT02794896

Anesthetic Depth Effects Upon Immune Competent Cells

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.

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Key information

Conditions

Immunotoxicity Anesthesia Chemically-Induced Disorders Gas Poisoning Inert Gas Narcosis Occupational Diseases Poisoning

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Mannheim, 68163, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High dose propofol, fentanyl and sevoflurane

Drug

Deep Anesthesia

Other names: BIS lower than or equal to 45

Low dose propofol, fentanyl and sevoflurane

Drug

Shallow Anesthesia

Other names: BIS above 45

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Registry information

Official study 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

Acronym: BIS-MA

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Jun 9, 2016
Registry last updated
May 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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