Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery (Decade)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
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
|United States, Ohio|
|Cleveland Clinic Main|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Alparslan Turan, MD||Staff member|