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

Information source: Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Suspected Delirium After Elective or Emergency Heart Surgery; CAM-ICU Diagnosed Delirium

Intervention: Physostigmine (Drug); Sodium Chloride solution (Other)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: PD Dr. Bertram Scheller

Official(s) and/or principal investigator(s):
Bertram Scheller, MD, Principal Investigator, Affiliation: Department of Anesthesiology, Intensive-Care Medicine and Pain Therapy of Goethe-University Frankfurt

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: change of vigilance or symptoms of the delirium measured by Richmond Agitation Sedation Score (RASS)

Secondary outcome:

reduction of weaning time at mechanical ventilator of patients with symptoms of delirium

change in the spontaneous EEG and auditory evoked potentials

impact of the variability of heart rate

change in development of muscular force

Occurence of Adverse events

Eligibility

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

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

Locations and Contacts

Department of Anesthesiology, Intensive-Care Medicine and Pain Therapy, Frankfurt, Hessia 60590, Germany
Additional Information

Starting date: April 2014
Last updated: August 11, 2014

Page last updated: August 23, 2015

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