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 |
| Protocol serial number | AM-KS-III/06/08 |
| Sponsor | Dr. Franz Köhler Chemie GmbH (Germany) |
| Funder | Dr. Franz Köhler Chemie GmbH (Germany) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Department of Cardiosurgery
Clinic for Surgery
University Hospital Heidelberg
Heidelberg
69120
Germany
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective, randomised, double-blind, placebo-controlled, parallel-group, phase III study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Physostigmine salicylate |
| Primary outcome measure(s) |
Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) test, assessed 30 minutes after the administration of IMP. |
| Key secondary outcome measure(s) |
1. Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) test, assessed 120 minutes after administration of IMP |
| Completion date | 01/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
69120
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
