Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery
NCT ID: NCT02004613
Last Updated: 2021-04-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
798 participants
INTERVENTIONAL
2013-06-30
2020-12-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Dexmedetomidine
Dexmedetomidine
Placebo
normal saline administration matching dexmedetomidine rate of infusion.
Placebo
Normal saline administration matching dexmedetomidine rate of infusion
Interventions
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Dexmedetomidine
Dexmedetomidine
Placebo
Normal saline administration matching dexmedetomidine rate of infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
85 Years
ALL
Yes
Sponsors
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Hospira, now a wholly owned subsidiary of Pfizer
INDUSTRY
The Cleveland Clinic
OTHER
Responsible Party
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Alparslan Turan
Staff
Principal Investigators
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Alparslan Turan, MD
Role: PRINCIPAL_INVESTIGATOR
Staff member
Locations
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Cleveland Clinic Main
Cleveland, Ohio, United States
Countries
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References
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Turan A, Duncan A, Leung S, Karimi N, Fang J, Mao G, Hargrave J, Gillinov M, Trombetta C, Ayad S, Hassan M, Feider A, Howard-Quijano K, Ruetzler K, Sessler DI; DECADE Study Group. Dexmedetomidine for reduction of atrial fibrillation and delirium after cardiac surgery (DECADE): a randomised placebo-controlled trial. Lancet. 2020 Jul 18;396(10245):177-185. doi: 10.1016/S0140-6736(20)30631-0.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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12-1379
Identifier Type: -
Identifier Source: org_study_id
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