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

Sponsor

PD Dr. Bertram Scheller (Other)

Overall Status

Unknown status

CT.gov ID

NCT02216266

Collaborator

University Hospital Frankfurt (Other), Dr. Franz Köhler Chemie GmbH (study medication and labeling) (Other)

120

Enrollment

Location

Arms

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Suspected Delirium After Elective or Emergency Heart Surgery CAM-ICU Diagnosed Delirium	Drug: Physostigmine Other: Sodium Chloride solution	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Monocenter, Double Blind, Randomised, Placebo Controlled Study to Evaluate Physostigmine for the Treatment of Delirium in Perioperative Intensive Care Medicine

Study Start Date :

Apr 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Physostigmine Physostigmine administered intravenously at a dose of 24 mg + 25 min a 0,04 mg/kg milligram(s)/kilogram	Drug: Physostigmine Other Names: Anticholium
Placebo Comparator: Sodium Chloride solution solution administered intravenously 24 mg + 25 min a 0,04 mg/kg milligram(s)/kilogram	Other: Sodium Chloride solution Other Names: NaCl solution as Placebo comparator

Arm

Intervention/Treatment

Active Comparator: Physostigmine

Physostigmine administered intravenously at a dose of 24 mg + 25 min a 0,04 mg/kg milligram(s)/kilogram

Drug: Physostigmine

Other Names:

Anticholium

Placebo Comparator: Sodium Chloride solution

solution administered intravenously 24 mg + 25 min a 0,04 mg/kg milligram(s)/kilogram

Other: Sodium Chloride solution

Other Names:

NaCl solution as Placebo comparator

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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