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Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery (Decade)

NeuroTherapia, Inc. logo

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

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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