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

Completed

• Conditions: Delirium during post-operative arousal; Mental and Behavioural Disorders; Delirium

• Registration Number: ISRCTN33122761
• Lead Sponsor: Dr. Franz Köhler Chemie GmbH (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-28
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 130

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified