Depth of Anesthesia and Proteomics

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

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).

Study Overview

• Status: Completed
• Conditions: Anesthesia Complication; Immune Suppression
• Intervention / Treatment: Drug: Shallow anesthesia; Drug: Deep anesthesia

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: Shallow anesthesia; Drug: Low dose propofol, fentanyl and sevoflurane Shallow Anesthesia Other Names: BIS above 45; Other Names: Light anesthesia
EXPERIMENTAL: 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.	Drug: Deep anesthesia; Drug: High dose propofol, fentanyl and sevoflurane Deep Anesthesia Other Names: BIS lower than or equal to 45; Other Names: Profound anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proteome: depression of immune stimulative proteins	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	70-90 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proteome: overexpression of immune depressive proteins	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	70-90 min

Collaborators and Investigators

• Sponsor: Heidelberg University
• Investigators: Study Chair: Thomas Frietsch, University of Heidelberg, Faculty Mannheim

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2009
• Primary Completion (ACTUAL): July 15, 2014
• Study Completion (ACTUAL): October 23, 2016

Study Registration Dates

• First Submitted: May 13, 2022
• First Submitted That Met QC Criteria: May 13, 2022
• First Posted (ACTUAL): May 19, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 13, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: TF-KliMa-2005-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No