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Reduction of Intraoperative EEG Burst Suppression (BsR)

Primary Purpose

Burst Suppression, EEG With Abnormally Slow Frequencies, Postoperative Delirium

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Treatment of hypotension and/or reduction of anesthetics
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Burst Suppression focused on measuring Intraoperative EEG based monitoring, Level of hypnosis, Burst suppression, Postoperative delirium, EEG-signal characteristics, Entropy

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • Klinikum rechts der Isar - Klinik fuer Anaesthesiologie und Intensivmedizin

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

1 - Blinded

2 - Unblinded

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Burst suppression rate during induction.
Rate of change of the burst suppression rate during induction.
Burst suppression rate during maintenance.
Rate of change of the burst suppression ratio during maintenance.
Mean arterial blood pressure.
Evaluation of the mean arterial blood pressure with positive burst suppression rate.
Endtidal anesthetic concentration (ETAC) and infusion rate of propofol.
Evaluation of the mean ETAC and infusion rate of propofol.
Specific characteristics of the EEG frequency spectrum during burst suppression
Evaluation of specific EEG frequencies differentiating BSR caused by hypotension or oversedation of anesthetics.
Postoperative delirium.
Screening of the patients regarding a postoperative delirium by a brief confession assessment method (bCAM).

Full Information

First Posted
November 22, 2018
Last Updated
May 10, 2021
Sponsor
Technical University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT03775356
Brief Title
Reduction of Intraoperative EEG Burst Suppression
Acronym
BsR
Official Title
Reduction of Intraoperative EEG Burst Suppression - Test of Efficacy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 8, 2019 (Actual)
Primary Completion Date
December 19, 2020 (Actual)
Study Completion Date
December 19, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technical University of Munich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Intraoperative burst suppression represents a non physiological EEG pattern. According to the literature and scientific knowledge, intraoperative burst suppression patterns might be caused either by hypotension resulting in a reduced cerebral circulation or by an oversedation of anesthetics correlating with a very deep level of hypnosis. Some publications exist that discuss the occurrence of intraoperative burst suppression especially in elderly people (aged ≥ 60 years) as a predictor of postoperative delirium and postoperative cognitive dysfunction. None of the studies however was able to prove a causal relationship between burst suppression and postoperative delirium. Contrary it might simply be an epiphenomenon. Conducting this interventional trail primarily aims to prove whether specific anesthesiological interventions, such as the treatment of intraoperative hypotension in first line and/or the reduction of the concentration of anesthetics in second line, reduce intraoperative burst suppression. Hence it might be possible to investigate a possible casualty between burst suppression and postoperative delirium in a second trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Masking Description
Single masked. The entropy and EEG module will be masked for the responsible anesthetist as well as the study team during the entire investigation.
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 - Blinded
Arm Type
No Intervention
Arm Description
EEG and Entropy will be blinded. The anesthesiological management will be performed by the anesthetist according to clinical standard operations.
Arm Title
2 - Unblinded
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment of hypotension and/or reduction of anesthetics
Intervention Description
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.
Primary Outcome Measure Information:
Title
Chance of the total, cumulative burst suppression rate.
Description
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).
Time Frame
During general anesthesia and within the intervention
Secondary Outcome Measure Information:
Title
Burst suppression rate during induction.
Description
Rate of change of the burst suppression rate during induction.
Time Frame
During induction within the intervention
Title
Burst suppression rate during maintenance.
Description
Rate of change of the burst suppression ratio during maintenance.
Time Frame
During maintenance within the intervention
Title
Mean arterial blood pressure.
Description
Evaluation of the mean arterial blood pressure with positive burst suppression rate.
Time Frame
During burst suppression within general anesthesia
Title
Endtidal anesthetic concentration (ETAC) and infusion rate of propofol.
Description
Evaluation of the mean ETAC and infusion rate of propofol.
Time Frame
During burst suppression within the intervention
Title
Specific characteristics of the EEG frequency spectrum during burst suppression
Description
Evaluation of specific EEG frequencies differentiating BSR caused by hypotension or oversedation of anesthetics.
Time Frame
During burst suppression within general anesthesia
Title
Postoperative delirium.
Description
Screening of the patients regarding a postoperative delirium by a brief confession assessment method (bCAM).
Time Frame
Within the first three postoperative days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Neurological or psychiatric disorders hearing difficulty deafness neurosurgical (intra)cranial surgery pregnancy expected continuous mandatory ventilation after surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Schneider, Prof. Dr.
Organizational Affiliation
Clinic director - Department of anesthesiology and intensive care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum rechts der Isar - Klinik fuer Anaesthesiologie und Intensivmedizin
City
München
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25928189
Citation
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.
Results Reference
background
PubMed Identifier
26418126
Citation
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.
Results Reference
background
PubMed Identifier
23539235
Citation
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.
Results Reference
background
PubMed Identifier
22546967
Citation
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.
Results Reference
background
PubMed Identifier
35308563
Citation
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.
Results Reference
derived

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Reduction of Intraoperative EEG Burst Suppression

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