Postoperative Confusion
Conditions
Keywords
Prevention delirium, Cardiac surgery
Brief 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.
Interventions
DRUGHaloperidol
1mg the night before and 1mg the morning of surgery; OR Haloperidol 2mg the morning of surgery
DRUGPlacebo
1 dose the night before and 1 dose the morning of surgery; OR 2 doses the morning of surgery
Sponsors
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of conducting a trial utilizing low dose Haloperidol use in patients post cardiac surgery | Participants will be followed for the duration of their hospital stay to a maximum of 30 days. | 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 |
| Safety monitoring of low dose Haloperidol use in patients post cardiac surgery | Participants will be followed for the duration of their hospital stay to a maximum of 30 days | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Total length of stay (LOS), with breakdown for intensive care unit (ICU) days and ward days | Participants will be followed for the duration of their hospital stay to a maximum of 30 days |
| The incidence of delirium | Participants will be followed for the duration of their hospital stay to a maximum of 30 days |
| Duration of delirium | Participants will be followed for the duration of their hospital stay to a maximum of 30 days |
| Delirium severity | Participants will be followed for the duration of their hospital stay to a maximum of 30 days |
Other
| Measure | Time frame |
|---|---|
| An economic analysis will be completed to determine if Haloperidol prophylaxis resulted in any cost savings | Participants will be followed for the duration of their hospital stay to a maximum of 30 days |
Countries
Canada
Outcome results
None listed