The Effect of Dexmedetomidine Infusion on Post-operative Cognitive Function and Oxidative Stress in Cardiac Surgery
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.
Timeline
- Start
- 2015-06
- Primary completion
- 2016-12
- Completion
- 2016-12
Outcome
Missed primary endpoint
registry analysis (superiority test); Dex Group vs Placebo Group; p = 0.289; Risk Ratio (RR) 1.532 (95% CI 0.689 to 3.406); Chi-squared NCT03054857 ↗
registry analysis (superiority test); Dex Group vs Placebo Group; p = 0.636; Risk Ratio (RR) 1.329 (95% CI 0.409 to 4.319); Chi-squared NCT03054857 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexmedetomidine | Other / unclassified | 0.4 ug/kg | Intravenous |