Suspected Delirium After Elective or Emergency Heart Surgery, CAM-ICU Diagnosed Delirium
Conditions
Keywords
Delirium, CAM-ICU
Brief summary
Evaluation if physostigmine reduces symptoms in patients who has developed a delirium in Intensive care after a surgery
Interventions
Sponsors
Goethe University
Dr. Franz Köhler Chemie GmbH (study medication and labeling)
PD Dr. Bertram Scheller
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients of both genders aged \> 18 years, \< 85 years of ICU C1 after elective or emergency heart surgery with or without extracorporeal circulation (heart-lung machine and/or extracorporeal membrane oxygenation), with suspected delirium. (May be suspected if a patient does not show adequate improvement of vigilance 24 h after adequate reduction or stop of sedative medicine) * Patients (\>18a, \<85a) with CAM-ICU diagnosed delirium * Patients of legal capacity and patients with appointed representative
Exclusion criteria
* Asthma * hypersensitivity against Physostigmine salicylate, Sodium metabisulfite, Nitrogen * gangrene mechanical obstipation * mechanical urinary retention * Dystrophia myotonica * Depolarization block after depolarising muscle relaxants * Intoxications with irreversibly acting cholinesterase inhibitors * closed head trauma * obstructions at gastro-intestinal tract and at urinary tract * neurological diseases * left ventricular ejection fraction \< 40% * Simultaneous Participation in other clinical trials or participation ind other clinical trials in the last 30 days * untreated coronary heart disease * wish to have children, pregnancy or nursing * patients with addictive disorder in medical history
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change of vigilance or symptoms of the delirium measured by Richmond Agitation Sedation Score (RASS) | baseline to 48 hours after administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| reduction of weaning time at mechanical ventilator of patients with symptoms of delirium | baseline to 48 hours after administration | — |
| change in the spontaneous EEG and auditory evoked potentials | baseline to 48 hours after administration | for the spontaneous EEG, we expect a shift in the frequency characteristics, measure is the spectrogram, more precisely the amplitude per frequency (band) and the phase information derived via Fourier Transform and Wavelet transformation The paradigm of the auditory stimulation is a roving paradigm (Science 13 May 2011: Vol. 332 no. 6031 pp. 858-862 DOI: 10.1126/science.1202043 •Report Preserved Feedforward But Impaired Top-Down Processes in the Vegetative State Melanie Boly1,2,\*, Marta Isabel Garrido2, Olivia Gosseries1, Marie-Aurélie Bruno1, Pierre Boveroux3, Caroline Schnakers1, Marcello Massimini4, Vladimir Litvak2, Steven Laureys1, Karl Friston2) Measures will be differences in the mismatch negativity and in the phase synchronization between electrodes |
| impact of the variability of heart rate | baseline to 48 hours | heart rate variability is a dimensionless parameter, assessing the variability of the heart rate from ECG measures (Heart Rate Variability Conny M. A. van Ravenswaaij-Arts, MD; Louis A. A. Kollee, MD, PhD; Jeroen C. W. Hopman, MSc; Gerard B. A. Stoelinga, MD, PhD; and Herman P. van Geijn, MD, PhD \[+-\] Article and Author Information Ann Intern Med. 1993;118(6):436-447. doi:10.7326/0003-4819-118-6-199303150-00008 ) |
| change in development of muscular force | baseline up to 48 hours | muscular force is measured with a force gauge, measured in \[Newton\] |
| Occurence of Adverse events | baseline to 4 weeks after treatment | — |
Countries
Germany
Contacts
Primary ContactBertram Scheller, MD
Outcome results
None listed