NCT05380778

Depth of Anesthesia and Proteomics

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Heidelberg University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anesthesia Complication
• Immune Suppression

Interventions

Type	Name	Description
DRUG	Deep anesthesia	Drug: High dose propofol, fentanyl and sevoflurane Deep Anesthesia Other Names: BIS lower than or equal to 45
DRUG	Shallow anesthesia	Drug: Low dose propofol, fentanyl and sevoflurane Shallow Anesthesia Other Names: BIS above 45

Timeline

• Start date: 2009-03-01
• Primary completion: 2014-07-15
• Completion: 2016-10-23
• First posted: 2022-05-19
• Last updated: 2022-05-19