Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery (Decade)
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|ClinicalTrials.gov Identifier: NCT02004613|
Recruitment Status : Completed
First Posted : December 9, 2013
Results First Posted : April 6, 2021
Last Update Posted : April 6, 2021
|Condition or disease||Intervention/treatment||Phase|
|Heart Disease||Drug: Dexmedetomidine Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||798 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|
|Actual Study Completion Date :||December 18, 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
- Number of Patients With Atrial Arrhythmia [ Time Frame: From the end of surgery to postoperative day 5 ]The occurrence of postoperative atrial arrhythmias
- Number of Patients With Delirium [ Time Frame: From the end of surgery to postoperative day 5 ]The occurrence of postoperative delirium
- Number of Patients With Acute Kidney Injury [ Time Frame: From the end of surgery to postoperative day 5 ]Acute kidney injury is defined according to Acute Kidney Injury Network (AKIN) classifications. No risk means no risk of acute kidney injury, while a higher stage means worse kidney function.
- Number of Patients With Incisional Pain [ Time Frame: 90 days after surgery ]Patients were evaluated at 90 days by modified Brief Pain Inventory.
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|