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| Name | Class |
|---|---|
| Emory University | OTHER |
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Aim of this observational study is to investigate whether frontal electroencephalogram analysis is able to predict increased risk for PACU delirium.
Delirium in the postoperative anaesthesia care unit (PACU), a special of form of postoperative delirium, is associated with increased hospital stay and an elevated hospital re-admission rate. First studies investigating the patients' electroencephalogram (EEG) on emergence from anaesthesia were able to show that an abrupt change of predominant EEG-rhythm is associated with an increased rate of PACU delirium. Therefore, it seems possible to use frontal EEG in order to identify patients being at elevated risk for PACU delirium.
Aim of this observational study is to validate the results of an international collaboration in a German population of patients undergoing general anaesthesia. EEG in these patients is recorded from start of anaesthesia until emergence. Rate of PACU delirium is assessed using the CAM-ICU score 15 and 60 minutes after emergence in the recovery room.
In a pilot study in 626 patients from 2013 to 2015 in 5 international study centres the rate of PACU delirium was 20%. As it is planned to investigate 5 co-factors using regression analysis 50 cases of delirium will be necessary for a sufficient analysis. Therefore, in total 250 patients will be included.
Due to an additional study centre that included 50 patients enrolment of the german validation group was completed after 200 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with general anesthesia | Patients with general anaesthesia are monitored with electroencephalography and the results will be associated with the risk for PACU delirium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electroencephalography | Device | Patients electroencephalogram will be recorded |
|
| Measure | Description | Time Frame |
|---|---|---|
| PACU Delirium | Detection of delirium in the postoperative anaesthesia care unit using CAM-ICU score | Emergence from anaesthesia until discharge from postoperative anaesthesia care unit (60 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain in the PACU (NRS) | Pain assessed with numeric rating scale | Emergence from anaesthesia until discharge from postoperative anaesthesia care unit (60 minutes) |
| Electroencephalography | Electroencephalography recording |
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Inclusion Criteria:
Exclusion Criteria:
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All patients above the age of 18 years undergoing general anaesthesia
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| Name | Affiliation | Role |
|---|---|---|
| Sebastian Schmid, MD | Klinikum rechts der Isar - Dept. of Anaesthesiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum rechts der Isar Dept. of Anesthesiology | Munich | 81675 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12799407 | Background | Ely EW, Truman B, Shintani A, Thomason JW, Wheeler AP, Gordon S, Francis J, Speroff T, Gautam S, Margolin R, Sessler CN, Dittus RS, Bernard GR. Monitoring sedation status over time in ICU patients: reliability and validity of the Richmond Agitation-Sedation Scale (RASS). JAMA. 2003 Jun 11;289(22):2983-91. doi: 10.1001/jama.289.22.2983. | |
| 36049381 |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004569 | Electroencephalography |
| ID | Term |
|---|---|
| D003943 | Diagnostic Techniques, Neurological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
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| Pre-induction until emergence from anaesthesia (average of 3 hours) |
| Lutz R, Muller C, Dragovic S, Schneider F, Ribbe K, Anders M, Schmid S, Garcia PS, Schneider G, Kreuzer M, Kratzer S. The absence of dominant alpha-oscillatory EEG activity during emergence from delta-dominant anesthesia predicts neurocognitive impairment- results from a prospective observational trial. J Clin Anesth. 2022 Nov;82:110949. doi: 10.1016/j.jclinane.2022.110949. Epub 2022 Aug 29. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |