Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery (Decade)

NeuroTherapia, Inc.

Status and phase: Completed; Phase 4

Conditions: Heart Disease

Treatments: Drug: Dexmedetomidine; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02004613

12-1379

Details and patient eligibility

About

Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery

Full description

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

Enrollment: 798 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 18-85 years old;
2. Scheduled for cardiac surgery with bypass (CABG, valve, or combined);
3. Able to provide a written informed consent;
4. Hemodynamically stable (heart rate>= 55).

Exclusion criteria

1. Sick sinus syndrome or Wolff-Parkinson-White syndrome
2. Atrio-ventricular block
3. Hypersensitivity or known allergy to dexmedetomidine
4. Hepatic disease, e.g. twice the normal level of liver enzymes
5. Atrial fibrillation within 1 preoperative month;
6. Permanent pacemaker;
7. Use of amiodarone or dexmedetomidine within the last 30 days;
8. Patients with an ejection fraction under 30% or who had severe heart failure
9. Myocardial infarction in the previ¬ous 7 days;
10. Body mass index =< 40 (BMI= mass (kg) / height (m)2);
11. Those taking clonidine within last 48 hours.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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798 participants in 2 patient groups, including a placebo group

Dexmedetomidine

Active Comparator group

Description:

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.

Treatment:

Drug: Dexmedetomidine

Placebo

Placebo Comparator group

Description:

normal saline administration matching dexmedetomidine rate of infusion.

Treatment:

Drug: Placebo