Klinikum rechts der Isar - Klinik fuer Anaesthesiologie und Intensivmedizin
München, Bavaria, 81675, Germany
NCT Number: NCT03775356
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.
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Notify Me60 year and older
All sexes
Interventional
Not applicable
München, Bavaria, 81675, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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).
Time frame: During induction within the intervention
Rate of change of the burst suppression rate during induction.
Time frame: During maintenance within the intervention
Rate of change of the burst suppression ratio during maintenance.
Time frame: During burst suppression within general anesthesia
Evaluation of the mean arterial blood pressure with positive burst suppression rate.
Time frame: During burst suppression within the intervention
Evaluation of the mean ETAC and infusion rate of propofol.
Time frame: During burst suppression within general anesthesia
Evaluation of specific EEG frequencies differentiating BSR caused by hypotension or oversedation of anesthetics.
Time frame: Within the first three postoperative days
Screening of the patients regarding a postoperative delirium by a brief confession assessment method (bCAM).
Technical University of Munich
Other
Reduction of Intraoperative EEG Burst Suppression - Test of Efficacy
Acronym: BsR
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