Reduction of Intraoperative EEG Burst Suppression (BsR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03775356|
Recruitment Status : Recruiting
First Posted : December 13, 2018
Last Update Posted : September 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Burst Suppression EEG With Abnormally Slow Frequencies Postoperative Delirium||Other: Treatment of hypotension and/or reduction of anesthetics||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Investigator)|
|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.|
|Official Title:||Reduction of Intraoperative EEG Burst Suppression - Test of Efficacy|
|Actual Study Start Date :||December 15, 2018|
|Estimated Primary Completion Date :||February 1, 2021|
|Estimated Study Completion Date :||March 31, 2021|
No Intervention: 1 - Blinded
EEG and Entropy will be blinded. The anesthesiological management will be performed by the anesthetist according to clinical standard operations.
Active Comparator: 2 - Unblinded
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
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.
- Chance of the total, cumulative burst suppression rate. [ Time Frame: During general anesthesia and within the intervention ]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).
- Burst suppression rate during induction. [ Time Frame: During induction within the intervention ]Rate of change of the burst suppression rate during induction.
- Burst suppression rate during maintenance. [ Time Frame: During maintenance within the intervention ]Rate of change of the burst suppression ratio during maintenance.
- Mean arterial blood pressure. [ Time Frame: During burst suppression within general anesthesia ]Evaluation of the mean arterial blood pressure with positive burst suppression rate.
- Endtidal anesthetic concentration (ETAC) and infusion rate of propofol. [ Time Frame: During burst suppression within the intervention ]Evaluation of the mean ETAC and infusion rate of propofol.
- Specific characteristics of the EEG frequency spectrum during burst suppression [ Time Frame: During burst suppression within general anesthesia ]Evaluation of specific EEG frequencies differentiating BSR caused by hypotension or oversedation of anesthetics.
- Postoperative delirium. [ Time Frame: Within the first three postoperative days ]Screening of the patients regarding a postoperative delirium by a brief confession assessment method (bCAM).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775356
|Contact: Gerhard Schneider, Prof. Dr.||0049-89-4140-4291||AINS@mri.tum.de|
|Contact: Stefanie Pilge, PD Dr.||0049-89-4140-4291||AINS@mri.tum.de|
|Klinikum rechts der Isar - Klinik fuer Anaesthesiologie und Intensivmedizin||Recruiting|
|München, Bayern, Germany, 81675|
|Contact: Gerhad Schneider, Prof. Dr. 0049-89-4140-4291 AINS@mri.tum.de|
|Principal Investigator:||Gerhard Schneider, Prof. Dr.||Clinic director - Department of anesthesiology and intensive care|