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

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PD Dr. Bertram Scheller
• Collaborators: Dr. Franz Köhler Chemie GmbH (study medication and labeling); University Hospital, Frankfurt
• Treatments: Pharmaceutical Solutions; Physostigmine

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