Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
AM-KS-III/06/08
Study information
Scientific title
Acronym
Study hypothesis
Physostigmine salicylate increases the probability to recover from a post-operative delirium 30 minutes after its administration assessed by use of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) test compared to placebo.
Ethics approval
Not provided at time of registration
Study design
Prospective, randomised, double-blind, placebo-controlled, parallel-group, phase III study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Delirium during post-operative arousal
Intervention
Single administration of physostigmine salicylate 0.03 mg per kg body weight (b.w.) administered intravenously versus placebo.
Intervention type
Drug
Phase
Phase III
Drug names
Physostigmine salicylate
Primary outcome measures
Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) test, assessed 30 minutes after the administration of IMP.
Secondary outcome measures
1. Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) test, assessed 120 minutes after administration of IMP
2. Serumanticholinergic Activity (SAA) assessed 60 minutes after administration of IMP
3. Richmond Agitation and Sedation Scales (RASS), assessed 30 and 120 minutes after administration of IMP
4. Adverse events up to 120 minutes after administration of IMP
5. Vital signs (blood pressure, heart rate, filling pressures and oxygen saturation) documented 10, 20, 30, 60 and 120 minutes after administration of IMP
Overall trial start date
01/12/2008
Overall trial end date
01/12/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Both males and females, aged greater than or equal to 18 and less than 90 years
2. Informed consent
3. Indication for an elective ACVB under mild hypothermia (34°C)
4. Negative pregnancy test in females of childbearing potential
5. Ability of subjects to understand the nature of the study
6. Delirium during the post-operative arousal
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
130
Participant exclusion criteria
1. Known neurologic deficits
2. Arterial occlusive disease (AOD), grade IIb
3. Glaucoma with retinal damage
4. Asthma or chronic obstructive pulmonary disease (COPD) (forced expiratory volume in 1 second [FEV1] less than 70%)
5. Acute bleeding
6. Acute renal insufficiency
7. Use of a circulation support system
8. Body weight greater than 130 kg
9. Concurrent participation in another interventional trial
10. Concurrent treatment of cerebral dysfunction or cerebral circulatory disorders
11. Known intolerability/hypersensitivity to the investigational medicinal product (IMP) or applied pharmaceutical ingredients or other remedies with similar chemical structure
Recruitment start date
01/12/2008
Recruitment end date
01/12/2009
Locations
Countries of recruitment
Germany
Trial participating centre
Department of Cardiosurgery
Heidelberg
69120
Germany
Sponsor information
Organisation
Dr. Franz Köhler Chemie GmbH (Germany)
Sponsor details
Neue Bergstrasse 3-7
Alsbach-Hähnlein
64665
Germany
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Dr. Franz Köhler Chemie GmbH (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary