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

PD Dr. Bertram Scheller

Status and phase: Unknown; Phase 3

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

Treatments: Other: Sodium Chloride solution; Drug: Physostigmine

Study type: Interventional

Funder types: Other

Identifiers

NCT02216266

DELIcu

2012-004082-41 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups, including a placebo group

Physostigmine

Active Comparator group

Description:

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

Treatment:

Drug: Physostigmine

Sodium Chloride solution

Placebo Comparator group

Description:

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

Treatment:

Other: Sodium Chloride solution