Reduction of Intraoperative EEG Burst Suppression

NCT03775356 | Completed

• 1 other identifier: BsR
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

Burst suppression (BS) is a not physiological pattern in the electroencephalogram (EEG). BS during general anesthesia is mainly seen as a sign for too deep hypnosis and may increase the risk of postoperative delirium (POD), a disturbance of consciousness arising within 24 hours after surgery. This monocentric, simple masked randomized study aims primarily to investigate, whether particular anesthesiological interventions reduce the occurrence of intraoperative burst suppression. The investigator initiated trial includes 66 patients (male and female) aged ≥ 60 years in two groups (intervention and control group). Secondary aims will be the correlation of burst suppression and mean arterial pressure, concentration of anesthetics and postoperative delirium.

Conditions

Burst Suppression; EEG With Abnormally Slow Frequencies; Postoperative Delirium

Keywords

Intraoperative EEG based monitoring; Level of hypnosis; Burst suppression; Postoperative delirium; EEG-signal characteristics; Entropy

Outcome Measures

Primary Outcomes (1)

• Chance of the total, cumulative burst suppression rate.

  The total, cumulative burst suppression rate (BSR) corresponds to area under the curve and is defined by the BSR (%) and the absolute duration of BSR (t).

  During general anesthesia and within the intervention

Secondary Outcomes (6)

• Burst suppression rate during induction.

  During induction within the intervention

• Burst suppression rate during maintenance.

  During maintenance within the intervention

• Mean arterial blood pressure.

  During burst suppression within general anesthesia

• Endtidal anesthetic concentration (ETAC) and infusion rate of propofol.

  During burst suppression within the intervention

• Specific characteristics of the EEG frequency spectrum during burst suppression

  During burst suppression within general anesthesia

Study Arms (2)

1 - Blinded

NO INTERVENTION

EEG and Entropy will be blinded. The anesthesiological management will be performed by the anesthetist according to clinical standard operations.

2 - Unblinded

ACTIVE COMPARATOR

EEG and Entropy will be unblinded. The intervention starts with the start of a positive burst suppression rate. In the case of a concurrent hypotension the anesthetist treats the hypotension according to clinical standard operations in the first step. Hypotension means blood pressure values blow the baseline value which is defined by the lowest, preoperatively measured value. If after this treatment and a reevaluation of the BSR, BSR remains positive, the anesthetist is going to reduce the concentration of anesthetics in a second step. In case of positive BSR and a blood pressure value ≥ the baseline value, the concentration of anesthetics will be reduced as a first measure. The aim is to figure out whether one or both of these interventions can reduce to total, cumulative BSR.

Other: Treatment of hypotension and/or reduction of anesthetics

Interventions

Treatment of hypotension and/or reduction of anesthetics OTHER

The treatment of hypotension can be done by the responsible anesthetist according to the clinical standard operations including any accepted drug typically used in this hospital. The reduction of anesthetics can be done either by reducing the volatile end tidal anesthetics concentration (ETAC) or the infusion rate of propofol.

2 - Unblinded

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 60 years
• Surgical interventions in general anesthesia (volatile or total intravenous anesthesia)
• expected surgery duration ≥ 1h
• American Society of Anesthesiologists (ASA) 1-4
• written informed consent prior to study participation

You may not qualify if:

• Neurological or psychiatric disorders
• hearing difficulty
• deafness
• neurosurgical (intra)cranial surgery
• pregnancy
• expected continuous mandatory ventilation after surgery

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Klinikum rechts der Isar - Klinik fuer Anaesthesiologie und Intensivmedizin

München, Bavaria, 81675, Germany

Location

Related Publications (7)

• Soehle M, Dittmann A, Ellerkmann RK, Baumgarten G, Putensen C, Guenther U. Intraoperative burst suppression is associated with postoperative delirium following cardiac surgery: a prospective, observational study. BMC Anesthesiol. 2015 Apr 28;15:61. doi: 10.1186/s12871-015-0051-7.

  PMID: 25928189 BACKGROUND

• Fritz BA, Kalarickal PL, Maybrier HR, Muench MR, Dearth D, Chen Y, Escallier KE, Ben Abdallah A, Lin N, Avidan MS. Intraoperative Electroencephalogram Suppression Predicts Postoperative Delirium. Anesth Analg. 2016 Jan;122(1):234-42. doi: 10.1213/ANE.0000000000000989.

  PMID: 26418126 BACKGROUND

• Radtke FM, Franck M, Lendner J, Kruger S, Wernecke KD, Spies CD. Monitoring depth of anaesthesia in a randomized trial decreases the rate of postoperative delirium but not postoperative cognitive dysfunction. Br J Anaesth. 2013 Jun;110 Suppl 1:i98-105. doi: 10.1093/bja/aet055. Epub 2013 Mar 28.

  PMID: 23539235 BACKGROUND

• Sessler DI, Sigl JC, Kelley SD, Chamoun NG, Manberg PJ, Saager L, Kurz A, Greenwald S. Hospital stay and mortality are increased in patients having a "triple low" of low blood pressure, low bispectral index, and low minimum alveolar concentration of volatile anesthesia. Anesthesiology. 2012 Jun;116(6):1195-203. doi: 10.1097/ALN.0b013e31825683dc.

  PMID: 22546967 BACKGROUND

• Schussler J, Ostertag J, Georgii MT, Fleischmann A, Schneider G, Pilge S, Kreuzer M. Preoperative characterization of baseline EEG recordings for risk stratification of post-anesthesia care unit delirium. J Clin Anesth. 2023 Jun;86:111058. doi: 10.1016/j.jclinane.2023.111058. Epub 2023 Jan 25.

  PMID: 36706658 DERIVED

• Fleischmann A, Georgii MT, Schuessler J, Schneider G, Pilge S, Kreuzer M. Always Assess the Raw Electroencephalogram: Why Automated Burst Suppression Detection May Not Detect All Episodes. Anesth Analg. 2023 Feb 1;136(2):346-354. doi: 10.1213/ANE.0000000000006098. Epub 2022 Jun 2.

  PMID: 35653440 DERIVED

• Georgii MT, Kreuzer M, Fleischmann A, Schuessler J, Schneider G, Pilge S. Targeted Interventions to Increase Blood Pressure and Decrease Anaesthetic Concentrations Reduce Intraoperative Burst Suppression: A Randomised, Interventional Clinical Trial. Front Syst Neurosci. 2022 Mar 4;16:786816. doi: 10.3389/fnsys.2022.786816. eCollection 2022.

  PMID: 35308563 DERIVED

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Gerhard Schneider, Prof. Dr.

  Clinic director - Department of anesthesiology and intensive care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: Single masked. The entropy and EEG module will be masked for the responsible anesthetist as well as the study team during the entire investigation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2018
• First Posted: December 13, 2018
• Study Start: January 8, 2019
• Primary Completion: December 19, 2020
• Study Completion: December 19, 2020
• Last Updated: May 11, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)