Clinical trial NCT02216266: Evaluation if Physostigmine Reduces Symptoms in Patients Who Has Developed a Delirium in Intensive Care After a Surgery
Official title: Monocenter, Double Blind, Randomised, Placebo Controlled Study to Evaluate Physostigmine for the Treatment of Delirium in Perioperative Intensive Care Medicine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Suspected Delirium After Elective or Emergency Heart Surgery
CAM-ICU Diagnosed Delirium
Keywords: Delirium
CAM-ICU
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
Collaborators: name: Goethe University
name: Dr. Franz Köhler Chemie GmbH (study medication and labeling)
First posted: 2014-08-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: change of vigilance or symptoms of the delirium measured by Richmond Agitation Sedation Score (RASS)
timeFrame: baseline to 48 hours after administration
Secondary outcomes:
measure: reduction of weaning time at mechanical ventilator of patients with symptoms of delirium
timeFrame: baseline to 48 hours after administration
measure: change in the spontaneous EEG and auditory evoked potentials
timeFrame: baseline to 48 hours after administration
measure: impact of the variability of heart rate
timeFrame: baseline to 48 hours
measure: change in development of muscular force
timeFrame: baseline up to 48 hours
measure: Occurence of Adverse events
timeFrame: baseline to 4 weeks after treatment
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Department of Anesthesiology, Intensive-Care Medicine and Pain Therapy
state: Hessia
Study officials:
affiliation: Department of Anesthesiology, Intensive-Care Medicine and Pain Therapy of Goethe-University Frankfurt
name: Bertram Scheller, MD
role: PRINCIPAL_INVESTIGATOR
References: