Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02216266
Recruitment Status : Unknown
Verified March 2017 by PD Dr. Bertram Scheller, Johann Wolfgang Goethe University Hospital.
Recruitment status was:  Recruiting
First Posted : August 13, 2014
Last Update Posted : March 10, 2017
Sponsor:
Collaborators:
University Hospital Frankfurt
Dr. Franz Köhler Chemie GmbH (study medication and labeling)
Information provided by (Responsible Party):
PD Dr. Bertram Scheller, Johann Wolfgang Goethe University Hospital

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

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 Name: 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 Name: NaCl solution as Placebo comparator




Primary Outcome Measures :
  1. change of vigilance or symptoms of the delirium measured by Richmond Agitation Sedation Score (RASS) [ Time Frame: baseline to 48 hours after administration ]

Secondary Outcome Measures :
  1. reduction of weaning time at mechanical ventilator of patients with symptoms of delirium [ Time Frame: baseline to 48 hours after administration ]
  2. change in the spontaneous EEG and auditory evoked potentials [ Time Frame: 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


  3. impact of the variability of heart rate [ Time Frame: 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 )


  4. change in development of muscular force [ Time Frame: baseline up to 48 hours ]
    muscular force is measured with a force gauge, measured in [Newton]

  5. Occurence of Adverse events [ Time Frame: baseline to 4 weeks after treatment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02216266


Contacts
Layout table for location contacts
Contact: Bertram Scheller, MD bertram.scheller@kgu.de

Locations
Layout table for location information
Germany
Department of Anesthesiology, Intensive-Care Medicine and Pain Therapy Recruiting
Frankfurt, Hessia, Germany, 60590
Principal Investigator: Bertram Scheller, MD         
Sponsors and Collaborators
PD Dr. Bertram Scheller
University Hospital Frankfurt
Dr. Franz Köhler Chemie GmbH (study medication and labeling)
Investigators
Layout table for investigator information
Principal Investigator: Bertram Scheller, MD Department of Anesthesiology, Intensive-Care Medicine and Pain Therapy of Goethe-University Frankfurt
Layout table for additonal information
Responsible Party: PD Dr. Bertram Scheller, PD MD Bertram Scheller, Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier: NCT02216266    
Other Study ID Numbers: DELIcu
2012-004082-41 ( EudraCT Number )
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017
Keywords provided by PD Dr. Bertram Scheller, Johann Wolfgang Goethe University Hospital:
Delirium
CAM-ICU
Additional relevant MeSH terms:
Layout table for MeSH terms
Delirium
Emergencies
Disease Attributes
Pathologic Processes
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Pharmaceutical Solutions
Physostigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Miotics
Autonomic Agents
Peripheral Nervous System Agents