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Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery (Decade)

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ClinicalTrials.gov Identifier: NCT02004613
Recruitment Status : Active, not recruiting
First Posted : December 9, 2013
Last Update Posted : July 24, 2019
Sponsor:
Collaborator:
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Alparslan Turan, The Cleveland Clinic

Brief Summary:
Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery

Condition or disease Intervention/treatment Phase
Heart Disease Drug: Dexmedetomidine Drug: Placebo Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 965 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery
Actual Study Start Date : June 2013
Actual Primary Completion Date : December 2018
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Active Comparator: Dexmedetomidine
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
Dexmedetomidine

Placebo Comparator: Placebo
normal saline administration matching dexmedetomidine rate of infusion.
Drug: Placebo
Normal saline administration matching dexmedetomidine rate of infusion
Other Name: Saline




Primary Outcome Measures :
  1. Sedation Outcome of patients assigned to dexmedetomidine or placebo. [ Time Frame: 3 to 90 Days after surgery ]
    To measure whether dexmedetomidine sedation decreases the incidence of atrial arrhythmias.


Secondary Outcome Measures :
  1. Sedation Outcome of patients assigned to dexmedetomidine or placebo [ Time Frame: 3 to 90 days after surgery ]
    To measure whether dexmedetomidine sedation reduces postoperative delirium.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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. AF 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 tak¬ing clonidine within last 48 hours.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004613


Locations
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United States, Ohio
Cleveland Clinic Main
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Hospira, now a wholly owned subsidiary of Pfizer
Investigators
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Principal Investigator: Alparslan Turan, MD Staff member

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Responsible Party: Alparslan Turan, Staff, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02004613     History of Changes
Other Study ID Numbers: 12-1379
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019

Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action