This trial is active, not recruiting.

Conditions suspected delirium after elective or emergency heart surgery, cam-icu diagnosed delirium
Treatments physostigmine, sodium chloride solution
Phase phase 3
Sponsor PD Dr. Bertram Scheller
Collaborator Ethic committee University Hospital Frankfurt
Start date April 2014
End date December 2015
Trial size 120 participants
Trial identifier NCT02216266, 2012-004082-41, DELIcu


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
Physostigmine administered intravenously at a dose of 24 mg + 25 min a 0,04 mg/kg milligram(s)/kilogram
physostigmine Anticholium
(Placebo Comparator)
solution administered intravenously 24 mg + 25 min a 0,04 mg/kg milligram(s)/kilogram
sodium chloride solution NaCl solution as Placebo comparator

Primary Outcomes

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

Secondary Outcomes

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
impact of the variability of heart rate
time frame: baseline to 48 hours
change in development of muscular force
time frame: baseline up to 48 hours
Occurence of Adverse events
time frame: baseline to 4 weeks after treatment

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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

Additional Information

Official title Monocenter, Double Blind, Randomised, Placebo Controlled Study to Evaluate Physostigmine for the Treatment of Delirium in Perioperative Intensive Care Medicine
Principal investigator Bertram Scheller, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Johann Wolfgang Goethe University Hospitals.