Efficacy and tolerability of physostigmine salicylate for treatment of post-operative delirium after aortocoronary-bypass operation (ACVB): a prospective, double-blind, placebo-controlled, two parallel-groups, phase III study

ISRCTN	ISRCTN33122761
DOI	https://doi.org/10.1186/ISRCTN33122761
Secondary identifying numbers	AM-KS-III/06/08

Submission date: 17/10/2008
Registration date: 28/11/2008
Last edited: 30/08/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Markus Verch
Scientific

Department of Cardiosurgery
Clinic for Surgery
University Hospital Heidelberg
Heidelberg
69120
Germany

Study information

Study design	Prospective, randomised, double-blind, placebo-controlled, parallel-group, phase III study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	Physostigmine salicylate
Primary outcome measure	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 study start date	01/12/2008
Completion date	01/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	130
Key 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
Key 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
Date of first enrolment	01/12/2008
Date of final enrolment	01/12/2009

Locations

Countries of recruitment

Germany

Study participating centre

Department of Cardiosurgery

Heidelberg
69120
Germany

Sponsor information

Dr. Franz Köhler Chemie GmbH (Germany)
Industry

Neue Bergstrasse 3-7
Alsbach-Hähnlein
64665
Germany

Website	http://www.koehler-chemie.de
"ROR"	https://ror.org/036ezxy46

Funders

Funder type

Industry

Dr. Franz Köhler Chemie GmbH (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan