Evaluation if Physostigmine Reduces Symptoms in Patients Who Has Developed a Delirium in Intensive Care After a Surgery

Phase 3

• Conditions: CAM-ICU Diagnosed Delirium; Suspected Delirium After Elective or Emergency Heart Surgery
• Interventions: Other: Sodium Chloride solution; Drug: Physostigmine

• Registration Number: NCT02216266
• Lead Sponsor: PD Dr. Bertram Scheller

Brief Summary

Evaluation if physostigmine reduces symptoms in patients who has developed a delirium in Intensive care after a surgery

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-17
• Study Start: 2014-04
• Study First Submitted QC: 2014-08-11
• Study First Posted: 2014-08-13
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-09
• Last Update Posted: 2017-03-10
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium Chloride solution	Sodium Chloride solution	solution administered intravenously 24 mg + 25 min a 0,04 mg/kg milligram(s)/kilogram
Physostigmine	Physostigmine	Physostigmine administered intravenously at a dose of 24 mg + 25 min a 0,04 mg/kg milligram(s)/kilogram

Primary Outcome Measures

Name	Time	Method
change of vigilance or symptoms of the delirium measured by Richmond Agitation Sedation Score (RASS)	baseline to 48 hours after administration

Secondary Outcome Measures

Name	Time	Method
reduction of weaning time at mechanical ventilator of patients with symptoms of delirium	baseline to 48 hours after administration
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
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

Trial Locations

Locations (1)

Department of Anesthesiology, Intensive-Care Medicine and Pain Therapy; 🇩🇪 Frankfurt, Hessia, Germany