Depth of Anesthesia and Proteomics

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05380778

Enrollment

Registered

2022-05-19

Start date

2009-03-01

Completion date

2016-10-23

Last updated

2022-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia Complication, Immune Suppression

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.

Interventions

DRUGDeep anesthesia

Drug: High dose propofol, fentanyl and sevoflurane Deep Anesthesia Other Names: BIS lower than or equal to 45

DRUGShallow anesthesia

Drug: Low dose propofol, fentanyl and sevoflurane Shallow Anesthesia Other Names: BIS above 45

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026