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OpenTrials
Completed

NCT Number: NCT05380778

Depth of Anesthesia and Proteomics

The primary aim of the study is to compare cellular activity of T-cells, NK-cells and monocytes after anesthesia. Phagocytosis and cellular lysis activity of neutrophils and monocytes are analyzed by flow cytometry. Secondly, we analyze anesthesia induced protein expresssion pattern in the blood. The proteome of monocytes is identified by 3D-gel-chromatography and mass spectrometry (MALDI-TOF).

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Key information

Conditions

Anesthesia Complication Immune Suppression

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Patients undergoing shoulder surgery in the orthopedic center are screened and consented to the randomized controlled, blinded study. Patients, surgeons, and the study personell involved in data interpretation and management are blinded towards the randomly assigned computerized group allocation (SAS, Cary, NC). The study director informs the anesthesiology staff about the group allocation. Patients are randomized to deep vs. light general anesthesia guided using a bispectral index monitor (BIS Vista, Aspect) with BIS < 45 in group 1 (deep anesthesia) or BIS ≥ 55 in group 2 (light anesthesia). Anesthesia depth is recorded via USB port every minute.

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

Deep anesthesia

Drug

Drug: High dose propofol, fentanyl and sevoflurane Deep Anesthesia

Other Names:

BIS lower than or equal to 45

Other names: Profound anesthesia

Shallow anesthesia

Drug

Drug: Low dose propofol, fentanyl and sevoflurane Shallow Anesthesia

Other Names:

BIS above 45

Other names: Light anesthesia

Primary outcomes

  1. Proteome: depression of immune stimulative proteins

    Time frame: 70-90 min

    Primary Outcome Measure:

    1.Depression of immune stimulating proteins in the proteom of maccrophages in in the 3-D- Gel electrophoresis as given in a percentage from before anesthesia before and following anesthesia period over 60 min

Secondary outcomes

  1. Proteome: overexpression of immune depressive proteins

    Time frame: 70-90 min

    Primary Outcome Measure:

    2.Overexpression of immune depressing proteins in the protein of maccrophages in in the 3-D- Gel electrophoresis as given in a percentage from before anesthesia before and following anesthesia period over 60 min

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Registry information

Official study title

BIS Controlled Anesthesia Depth is Associated With Different Protein and Peptide Expression in the Cerebrospinal Fluid

Important dates

Study start
2009
Primary completion
2014
Study completion
2016
First posted
May 19, 2022
Registry last updated
May 19, 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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