Anesthetic Depth Effects Upon Immune Competent Cells

NCT ID: NCT02794896

Last Updated: 2022-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2013-03-31

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.

Detailed Description

Blood samples were taken under minimal stress prior to anesthesia induction (T0), recovery (T1) and 12 weeks following hospital discharge (T2) from the respective anesthesia depth level. Bispectral index monitoring (BIS) was performed from the awake state to complete recovery in all subjects.

Hemoglobin concentration, leukocyte and lymphocyte counts were determined by routine automated laboratory techniques. Lymphocyte proliferation was analyzed by SASPA flow cytometry analysis. In brief, 100 µl EDTA blood were stirred with 10 µl FITC and PE marked antibody mixture containing CD3, CD4, CD8, CD 16, CD45, CD28, CD27, CD 56.

Monocyte and neutrophil phagocytosis activity was measured separately in macrophages of fresh heparinized whole blood using flow cytometric test kits.

Proteomics of monocytes was done synchronously.

Conditions

Immunotoxicity; Anesthesia; Inert Gas Narcosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Deep Anesthesia

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.

Group Type: EXPERIMENTAL

High dose propofol, fentanyl and sevoflurane

Intervention Type: DRUG

Deep Anesthesia

Shallow Anesthesia

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.

Group Type: EXPERIMENTAL

Low dose propofol, fentanyl and sevoflurane

Intervention Type: DRUG

Shallow Anesthesia

Interventions

High dose propofol, fentanyl and sevoflurane

Deep Anesthesia

Intervention Type: DRUG

Low dose propofol, fentanyl and sevoflurane

Shallow Anesthesia

Intervention Type: DRUG

Other Intervention Names

BIS lower than or equal to 45; BIS above 45

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heidelberg University

OTHER

Sponsor Role: lead

Responsible Party

Thomas Frietsch

Associate Professor of the Dept. of Anesthesiology and Critical Care Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Frietsch, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Mannheim

Locations

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

Mannheim, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 40097954 (View on PubMed)

Other Identifiers

Anesthetic depth-MA

Identifier Type: -

Identifier Source: org_study_id