Reducing Delirium After Cardiac Surgery: A Multifaceted Approach Of Perioperative Care

Study Overview
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Brief Summary
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The objective of this study is to reduce the incidence of postoperative delirium after cardiac surgery in the elderly patient. This proposal is a clinical trial designed to reduce delirium in patients undergoing cardiac surgery by replacing standard postoperative sedation protocols (propofol, midazolam, opioids) with a new alpha2-adrenergic receptor agonist (dexmedetomidine) possessing sedative, analgesic, and antinociceptive properties. Resource utilization analysis will be performed to determine cost effectiveness of the new treatment modality.

Detailed Description
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The proposed study will be a prospective, randomized, open label study comparing multimodal protocols for postoperative sedation after cardiac surgery. Patients will be randomly allocated to either dexmedetomidine or propofol (control) groups according to a computer generated randomization code in predetermined size blocks of four.

Official Title
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Reducing Delirium After Cardiac Surgery: A Multifaceted Approach Of Perioperative Care

Conditions
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Delirium, Cardiac Disease

Intervention / Treatment
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* Drug: Propofol
* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥60 years, undergoing high risk cardiac surgery, signed informed consent. Exclusion Criteria: Patients with symptomatic cerebrovascular disease, history of delirium, schizophrenia or preoperative use of psychotropic medications.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propofol<br>Upon arrival to ICU patients will receive a propofol 2-6mg/kg infusion until tracheal extubation | Drug: Propofol<br>* Upon arrival to ICU patients will receive a propofol 2-6mg/kg infusion until tracheal extubation<br>* Other names: Diprivan;|
| Active Comparator: Dexmedetomidine<br>Upon arrival to ICU patients will receive dexmedetomidine bolus of 0.4mcg/kg followed by an infusion of 0.2-0.7mcg/kg per hour for a maximum period of 24 hours. | Drug: Dexmedetomidine<br>* Upon arrival to ICU patients will receive dexmedetomidine bolus of 0.4mcg/kg followed by an infusion of 0.2-0.7mcg/kg per hour for a maximum period of 24 hours.<br>* Other names: Precedex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dichotomous outcome, a number of patients with delirium in the two study groups. | Assessment of delirium will be performed utilizing the CAM-ICU | up to 7 days postoperatively or discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total cost for each patient | Summation of direct-variable, direct-fixed, and overhead costs | Up to 7 days or discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac surgery, postoperative sedation, delirium