Clinical trial NCT03287401: Prediction of PACU Delirium Using EEG - German Validation Study
Official title: Prediction of Postoperative Anesthesia Care Unit Delirium Using Electroencephalography - German Validation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Keywords: EEG
PACU Delirium
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Emory University
First posted: 2017-09-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients above the age of 18 years undergoing general anaesthesia

Brief summary: Aim of this observational study is to investigate whether frontal electroencephalogram analysis is able to predict increased risk for PACU delirium.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* age: 18 years or older
* surgery in general anaesthesia

Exclusion Criteria:

* emergency surgery
* general anaesthesia within 30 days before

Primary outcomes:
measure: PACU Delirium
timeFrame: Emergence from anaesthesia until discharge from postoperative anaesthesia care unit (60 minutes)
Secondary outcomes:
measure: Pain in the PACU (NRS)
timeFrame: Emergence from anaesthesia until discharge from postoperative anaesthesia care unit (60 minutes)
measure: Electroencephalography
timeFrame: Pre-induction until emergence from anaesthesia (average of 3 hours)
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinikum rechts der Isar Dept. of Anesthesiology
Study officials:
affiliation: Klinikum rechts der Isar - Dept. of Anaesthesiology
name: Sebastian Schmid, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.