At a glance
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The Effect of Dexmedetomidine Infusion on Post-operative Cognitive Function and Oxidative Stress in Patients Undergo Cardiopulmonary Bypass Machine Facilitated Elective Cardiac Surgery
In Brief
A Phase 4 clinical trial evaluating Dexmedetomidine and Placebo for Oxidative Stress and Cognition Disorders. Completed, enrolled 100 participants.
Detailed Summary
Objective: The aim of this study was to determine the effect of dexmedetomidine in reducing postoperative cognitive dysfunction (POCD) in cardiac surgical patients which use cardiopulmonary bypass machine (CPB). Materials and Methods: This study was double-blinded, randomized controlled trial. Patients scheduled for elective CPB facilitated cardiac surgery were randomly assigned in two groups, dexmedetomidine group (DEX) or control group. The cognitive tests (MoCA test and Short bless test) were done before the operation, 48 hours, and 7 days postoperatively. POCD was defined as a decline of 1SD of baseline score in any test. Arterial blood sample were analyzed for IL-6, IL-10, TNF-alpha and hs-CRP before induction (T0), after separation from CPB (T1), arrival at ICU (T2) and 24-hour after surgery (T3). Primary outcome was the incidence of POCD and the secondary outcomes were inflammatory response, other postoperative complications, ICU and hospital stay.
Study Details
Timeline
Interventions
After skin incision, the dexmedetomidine group received a loading dose of 0.5 mcg/kg of Dexmedetomidine in 20 minutes followed by a continuous IV infusion at 0.4 mcg/kg/hr until the end of operation.
The control group received a loading dose and continuous IV infusion of normal saline at the same volume and rate as in the dexmedetomidine group