Depth of Anesthesia and Proteomics

NCT05380778 | Completed

• 1 other identifier: TF-KliMa-2005-2
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Anesthesia Complication; Immune Suppression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Proteome: overexpression of immune depressive proteins

  70-90 min

Study Arms (2)

Shallow Anesthesia

EXPERIMENTAL

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

Deep Anesthesia

EXPERIMENTAL

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

Interventions

Deep anesthesia DRUG

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

Also known as: Profound anesthesia

Deep Anesthesia

Shallow anesthesia DRUG

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

Also known as: Light anesthesia

Shallow Anesthesia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• enrolment for longer shoulder surgery consent for the standard anesthesia form in combination with the interscalene plexus block ASA Status 1-3

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg University: lead

Study Officials

• Thomas Frietsch

  University of Heidelberg, Faculty Mannheim

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: May 19, 2022
• Study Start: March 1, 2009
• Primary Completion: July 15, 2014
• Study Completion: October 23, 2016
• Last Updated: May 19, 2022

Record last verified: 2022-05