Depth of Anesthesia and Proteomics

Not Applicable

Completed

• Conditions: Anesthesia Complication; Immune Suppression
• Interventions: Drug: Shallow anesthesia; Drug: Deep anesthesia

• Registration Number: NCT05380778
• Lead Sponsor: Heidelberg University

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study Start: 2009-03-01
• Primary Completion: 2014-07-15
• Study Completion: 2016-10-23
• Status Verified: 2022-05
• Study First Submitted: 2022-05-13
• Study First Submitted QC: 2022-05-13
• Last Update Submitted: 2022-05-13
• Study First Posted: 2022-05-19
• Last Update Posted: 2022-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shallow Anesthesia	Shallow anesthesia	Experimental: Shallow Anesthesia Standard anesthesia with fentanyl, propofol for shoulder surgery together with an 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 ≥ 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.
Deep Anesthesia	Deep anesthesia	Experimental: Deep Anesthesia Standard anesthesia with fentanyl, propofol for shoulder surgery together with an 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 as measured by BIS monitors (BIS Vista, Aspect) for every minute and the minutes below a BIS level of 45 were counted.

Primary Outcome Measures

Name	Time	Method
Proteome: depression of immune stimulative proteins	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 Outcome Measures

Name	Time	Method
Proteome: overexpression of immune depressive proteins	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