Condition category
Mental and Behavioural Disorders
Date applied
17/10/2008
Date assigned
28/11/2008
Last edited
30/08/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Markus Verch

ORCID ID

Contact details

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

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

http://www.koehler-chemie.de

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

Publication citations

Additional files

Editorial Notes