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

Primary Purpose

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

Status

Unknown status

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

Physostigmine

Sodium Chloride solution

About this trial

This is an interventional treatment trial for Suspected Delirium After Elective or Emergency Heart Surgery focused on measuring Delirium, CAM-ICU

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Department of Anesthesiology, Intensive-Care Medicine and Pain TherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Physostigmine

Sodium Chloride solution

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

change in the spontaneous EEG and auditory evoked potentials

for the spontaneous EEG, we expect a shift in the frequency characteristics, measure is the spectrogram, more precisely the amplitude per frequency (band) and the phase information derived via Fourier Transform and Wavelet transformation The paradigm of the auditory stimulation is a roving paradigm (Science 13 May 2011: Vol. 332 no. 6031 pp. 858-862 DOI: 10.1126/science.1202043 •Report Preserved Feedforward But Impaired Top-Down Processes in the Vegetative State Melanie Boly1,2,*, Marta Isabel Garrido2, Olivia Gosseries1, Marie-Aurélie Bruno1, Pierre Boveroux3, Caroline Schnakers1, Marcello Massimini4, Vladimir Litvak2, Steven Laureys1, Karl Friston2) Measures will be differences in the mismatch negativity and in the phase synchronization between electrodes

impact of the variability of heart rate

heart rate variability is a dimensionless parameter, assessing the variability of the heart rate from ECG measures (Heart Rate Variability Conny M. A. van Ravenswaaij-Arts, MD; Louis A. A. Kollee, MD, PhD; Jeroen C. W. Hopman, MSc; Gerard B. A. Stoelinga, MD, PhD; and Herman P. van Geijn, MD, PhD [+-] Article and Author Information Ann Intern Med. 1993;118(6):436-447. doi:10.7326/0003-4819-118-6-199303150-00008 )

change in development of muscular force

muscular force is measured with a force gauge, measured in [Newton]

Occurence of Adverse events

Full Information

NCT ID

NCT02216266

First Posted

October 17, 2013

Last Updated

March 9, 2017

Sponsor

PD Dr. Bertram Scheller

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02216266

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Unknown status

Study Start Date

April 2014 (undefined)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

PD Dr. Bertram Scheller

Collaborators

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

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Delirium, CAM-ICU

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Physostigmine

Arm Type

Active Comparator

Arm Description

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

Arm Title

Sodium Chloride solution

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Physostigmine

Other Intervention Name(s)

Anticholium

Intervention Type

Other

Intervention Name(s)

Sodium Chloride solution

Other Intervention Name(s)

NaCl solution as Placebo comparator

Primary Outcome Measure Information:

Title

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

Time Frame

baseline to 48 hours after administration

Secondary Outcome Measure Information:

Title

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

Time Frame

baseline to 48 hours after administration

Title

change in the spontaneous EEG and auditory evoked potentials

Description

Time Frame

baseline to 48 hours after administration

Title

impact of the variability of heart rate

Description

Time Frame

baseline to 48 hours

Title

change in development of muscular force

Description

muscular force is measured with a force gauge, measured in [Newton]

Time Frame

baseline up to 48 hours

Title

Occurence of Adverse events

Time Frame

baseline to 4 weeks after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bertram Scheller, MD

bertram.scheller@kgu.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bertram Scheller, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Anesthesiology, Intensive-Care Medicine and Pain Therapy

City

Frankfurt

State/Province

Hessia

ZIP/Postal Code

60590

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bertram Scheller, MD

12. IPD Sharing Statement

Learn more about this trial

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

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