Haloperidol Prophylaxis in Cardiac Surgery for Patients at Risk for Delirium

McMaster University25 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Postoperative Confusion

Interventions

HaloperidolDRUG

1mg the night before and 1mg the morning of surgery; OR Haloperidol 2mg the morning of surgery

PlaceboDRUG

1 dose the night before and 1 dose the morning of surgery; OR 2 doses the morning of surgery

Eligibility

Sex: ALLMin age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Greater than or equal to 70 years of age, undergoing a median sternotomy OR 60-69yrs of age with one or more of the risk factors: * TIA/Stroke; * Euroscore greater than or equal to 5; * abnormal clock draw. Exclusion Criteria: * Parkinsonism, * on any antipsychotic medications pre-op, * active delirium, * emergent surgery, * Haloperidol allergy, * schizophrenia, * prolonged QTc.

Locations (1)

Hamilton General Site

Hamilton, Ontario, Canada

Outcomes

Primary Outcomes

Feasibility of conducting a trial utilizing low dose Haloperidol use in patients post cardiac surgery

If a participant does not develop delirium post operatively, then the confusion assessment method (CAM)will be monitored for 24 hours after the study medication ends. Patients will be followed up until seven days or until discharge if no delirium occurs, or if delirium is detected, up to 30 days or until discharge

Time frame: Participants will be followed for the duration of their hospital stay to a maximum of 30 days.

Safety monitoring of low dose Haloperidol use in patients post cardiac surgery