Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery (Decade)
|ClinicalTrials.gov Identifier: NCT02004613|
Recruitment Status : Active, not recruiting
First Posted : December 9, 2013
Last Update Posted : January 31, 2020
|Condition or disease||Intervention/treatment||Phase|
|Heart Disease||Drug: Dexmedetomidine Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||965 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Investigator)|
|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 :||December 31, 2020|
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.
Placebo Comparator: Placebo
normal saline administration matching dexmedetomidine rate of infusion.
Normal saline administration matching dexmedetomidine rate of infusion
Other Name: Saline
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004613
|United States, Ohio|
|Cleveland Clinic Main|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Alparslan Turan, MD||Staff member|