Anesthetic Depth Effects Upon Immune Competent Cells

NCT02794896 | Completed

• 1 other identifier: Anesthetic depth-MA
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Anesthesia depth affects the proliferation of lymphocytes to NK-cells and memory T-cells effect and the phagocytosis activity of macrophages in healthy patients. ASA 1-3 subjects undergoing extended shoulder surgery under continuous regional anesthesia randomly were assigned to a deep or a shallow anesthesia level (BIS \<35 or \>55) for more than an hour. Immune response is measured by lymphocyte proliferation as well as neutrophil and monocyte phagocytosis activity.

Conditions

Immunotoxicity; Anesthesia; Inert Gas Narcosis

Outcome Measures

Primary Outcomes (1)

• Depression of lymphocyte proliferation by CD expression pattern in SASPA-Test as given in a percentage from before anesthesia

  before and following anesthesia period over 60 min

  70-90 min

Secondary Outcomes (2)

• Reduction of phagocytosis activity as a percentage of base line (prior to anesthesia)

  70-90 min

• Protein expression pattern of monocytes by proteomics analysis and mass spectrometry

  70-90 min

Study Arms (2)

Deep Anesthesia

EXPERIMENTAL

Standard anesthesia with fentanyl, propofol for shoulder surgery together with a 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 was measured by BIS monitors (BIS Vista, Aspect) for every minute and the minutes below or equal to a BIS level of 45 were counted.

Drug: High dose propofol, fentanyl and sevoflurane

Shallow Anesthesia

EXPERIMENTAL

Standard anesthesia with fentanyl, propofol for shoulder surgery together with a inter scalene 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: Low dose propofol, fentanyl and sevoflurane

Interventions

High dose propofol, fentanyl and sevoflurane DRUG

Deep Anesthesia

Also known as: BIS lower than or equal to 45

Deep Anesthesia

Low dose propofol, fentanyl and sevoflurane DRUG

Shallow Anesthesia

Also known as: BIS above 45

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 Sites (1)

University Medicine of Mannheim, Dept. Anesthesiology and Critical Care Medicine

Mannheim, 68163, Germany

Location

Related Publications (1)

• Nguyen XD, Horn A, Fischer D, Beck G, Spannenberger CC, Gaudilliere B, Horn JL, Thierse HJ, Frietsch T. Suppressive effects of deep balanced anesthesia on cellular immunity and protein expression: a randomized-controlled pilot study. BMC Anesthesiol. 2025 Mar 17;25(1):129. doi: 10.1186/s12871-025-02980-9.

  PMID: 40097954 DERIVED

MeSH Terms

Conditions

Inert Gas Narcosis

Interventions

Propofol; Fentanyl; Sevoflurane

Condition Hierarchy (Ancestors)

Occupational Diseases; Gas Poisoning; Poisoning; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Thomas Frietsch, MD, PhD

  University of Mannheim

  PRINCIPAL INVESTIGATOR

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 of the Dept. of Anesthesiology and Critical Care Medicine

Study Record Dates

• First Submitted: May 12, 2016
• First Posted: June 9, 2016
• Study Start: March 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2013
• Last Updated: May 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)