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

NCT ID: NCT02216266

Last Updated: 2017-03-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2018-12-31

Brief Summary

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

Conditions

Suspected Delirium After Elective or Emergency Heart Surgery; CAM-ICU Diagnosed Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Physostigmine

Physostigmine administered intravenously at a dose of 24 mg + 25 min a 0,04 mg/kg milligram(s)/kilogram

Group Type: ACTIVE_COMPARATOR

Physostigmine

Intervention Type: DRUG

Sodium Chloride solution

solution administered intravenously 24 mg + 25 min a 0,04 mg/kg milligram(s)/kilogram

Group Type: PLACEBO_COMPARATOR

Sodium Chloride solution

Intervention Type: OTHER

Interventions

Physostigmine

Intervention Type: DRUG

Sodium Chloride solution

Intervention Type: OTHER

Other Intervention Names

Anticholium; NaCl solution as Placebo comparator

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Goethe University

OTHER

Sponsor Role: collaborator

Dr. Franz Köhler Chemie GmbH (study medication and labeling)

UNKNOWN

Sponsor Role: collaborator

PD Dr. Bertram Scheller

OTHER

Sponsor Role: lead

Responsible Party

PD Dr. Bertram Scheller

PD MD Bertram Scheller

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Bertram Scheller, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, Intensive-Care Medicine and Pain Therapy of Goethe-University Frankfurt

Locations

Department of Anesthesiology, Intensive-Care Medicine and Pain Therapy

Frankfurt, Hessia, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Bertram Scheller, MD

Role: CONTACT

bertram.scheller@kgu.de

Other Identifiers

2012-004082-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DELIcu

Identifier Type: -

Identifier Source: org_study_id