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

NCT02216266 | Unknown Phase 3

• 2 other identifiers: DELIcu2012-004082-41
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

Delirium; CAM-ICU

Outcome Measures

Primary Outcomes (1)

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

  baseline to 48 hours after administration

Secondary Outcomes (5)

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

  baseline to 48 hours after administration

• change in the spontaneous EEG and auditory evoked potentials

  baseline to 48 hours after administration

• impact of the variability of heart rate

  baseline to 48 hours

• change in development of muscular force

  baseline up to 48 hours

• Occurence of Adverse events

  baseline to 4 weeks after treatment

Study Arms (2)

Physostigmine

ACTIVE COMPARATOR

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

Drug: Physostigmine

Sodium Chloride solution

PLACEBO COMPARATOR

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

Other: Sodium Chloride solution

Interventions

Physostigmine DRUG

Also known as: Anticholium

Physostigmine

Sodium Chloride solution OTHER

Also known as: NaCl solution as Placebo comparator

Sodium Chloride solution

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PD Dr. Bertram Scheller: lead
• Goethe University: collaborator
• Dr. Franz Köhler Chemie GmbH (study medication and labeling): collaborator

Study Sites (1)

Department of Anesthesiology, Intensive-Care Medicine and Pain Therapy

Frankfurt, Hessia, 60590, Germany

RECRUITING

MeSH Terms

Conditions

Delirium

Interventions

Physostigmine; Sodium Chloride

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylcarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Bertram Scheller, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bertram Scheller, MD

CONTACT

bertram.scheller@kgu.de

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PD MD Bertram Scheller

Study Record Dates

• First Submitted: October 17, 2013
• First Posted: August 13, 2014
• Study Start: April 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 10, 2017

Record last verified: 2017-03

Locations

DE (1)