NCT01862302

Haloperidol Prophylaxis in Cardiac Surgery for Patients at Risk for Delirium

Haloperidol Prophylaxis in Cardiac Surgery for Patients at Risk for Delirium: A Randomized Placebo-Controlled Pilot Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: McMaster University · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

Will the use of prophylactic Haloperidol for patients undergoing open heart surgery reduce the incidence, duration, and severity of post cardiotomy delirium?

Detailed description

Pilot study for feasibility and safety, n = 40, haloperidol 1mg vs. placebo BID administered night before and day of surgery, then continued for total 72hrs post-op, if delirium occurs study drug is stopped and usual standard of care implemented by MRP.

Conditions

• Postoperative Confusion

Interventions

Type	Name	Description
DRUG	Haloperidol	1mg the night before and 1mg the morning of surgery; OR Haloperidol 2mg the morning of surgery
DRUG	Placebo	1 dose the night before and 1 dose the morning of surgery; OR 2 doses the morning of surgery

Timeline

• Start date: 2013-08-01
• Primary completion: 2015-09-01
• Completion: 2016-07-01
• First posted: 2013-05-24
• Last updated: 2016-09-16

Locations

1 site across 1 country: Canada