Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery

Study Overview
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Brief Summary
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Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery

Detailed Description
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The investigator goal is to evaluate the effects of intraoperative and postoperative dexmedetomidine sedation (versus placebo after cardiac surgery.

Official Title
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Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery

Conditions
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Heart Disease

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-85 years old; Scheduled for cardiac surgery with bypass (CABG, valve, or combined); Able to provide a written informed consent; Hemodynamically stable (heart rate>= 55). Exclusion Criteria: Sick sinus syndrome or Wolff-Parkinson-White syndrome Atrio-ventricular block Hypersensitivity or known allergy to dexmedetomidine Hepatic disease, e.g. twice the normal level of liver enzymes Atrial fibrillation within 1 preoperative month; Permanent pacemaker; Use of amiodarone or dexmedetomidine within the last 30 days; Patients with an ejection fraction under 30% or who had severe heart failure Myocardial infarction in the previ¬ous 7 days; Body mass index =< 40 (BMI= mass (kg) / height (m)2); Those taking clonidine within last 48 hours.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexmedetomidine<br>Dexmedetomidine infusion, without a bolus dose, (or a comparable volume of placebo) will be initiated before the surgical incision at a rate of 0.1 mcg/kg/hr at the end of bypass, the dose will be increased to 0.2 mcg/kg/hr. Postoperatively patients will continue to receive the study medication at a rate of 0.4mcg/kg/hr. The study medication infusion will be continued for a total of 24 hours from the initial administration time intra-operatively. | Drug: Dexmedetomidine<br>* Dexmedetomidine<br>|
| Placebo Comparator: Placebo<br>normal saline administration matching dexmedetomidine rate of infusion. | Drug: Placebo<br>* Normal saline administration matching dexmedetomidine rate of infusion<br>* Other names: Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Atrial Arrhythmia | The occurrence of postoperative atrial arrhythmias | From the end of surgery to postoperative day 5 | 
| Number of Patients With Delirium | The occurrence of postoperative delirium | From the end of surgery to postoperative day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Acute Kidney Injury | Acute kidney injury is defined according to Acute Kidney Injury Network (AKIN) classifications. No risk means no risk of acute kidney injury, while a higher stage means worse kidney function. | From the end of surgery to postoperative day 5 | 
| Number of Patients With Incisional Pain | Patients were evaluated at 90 days by modified Brief Pain Inventory. | 90 days after surgery |