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

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2018

Interventions

  • Drug: Physostigmine
  • Other: Sodium Chloride solution

Arms, Groups and Cohorts

  • Active Comparator: Physostigmine
    • Physostigmine administered intravenously at a dose of 24 mg + 25 min a 0,04 mg/kg milligram(s)/kilogram
  • Placebo Comparator: Sodium Chloride solution
    • solution administered intravenously 24 mg + 25 min a 0,04 mg/kg milligram(s)/kilogram

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • reduction of weaning time at mechanical ventilator of patients with symptoms of delirium
    • Time Frame: baseline to 48 hours after administration
  • 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
  • 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 )
  • change in development of muscular force
    • Time Frame: baseline up to 48 hours
    • muscular force is measured with a force gauge, measured in [Newton]
  • Occurence of Adverse events
    • Time Frame: baseline to 4 weeks after treatment

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • PD Dr. Bertram Scheller
  • Collaborator
    • University Hospital, Frankfurt
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: PD Dr. Bertram Scheller, PD MD Bertram Scheller – Johann Wolfgang Goethe University Hospital
  • Overall Official(s)
    • Bertram Scheller, MD, Principal Investigator, Department of Anesthesiology, Intensive-Care Medicine and Pain Therapy of Goethe-University Frankfurt
  • Overall Contact(s)
    • Bertram Scheller, MD, bertram.scheller@kgu.de

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