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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN33122761

Enrollment

130

Registered

2008-11-28

Start date

2008-12-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium during post-operative arousal Mental and Behavioural Disorders Delirium

Interventions

Single administration of physostigmine salicylate 0.03 mg per kg body weight (b.w.) administered intravenously versus placebo.

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) test, assessed 30 minutes after the administration of IMP.	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026