At a glance
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Impact of Dexmedetomidine on the Incidence of Postoperative Delirium in Patients After Cardiac Surgery: a Randomized, Double-blinded, and Placebo-controlled Clinical Trial
In Brief
A Phase 4 clinical trial evaluating dexmedetomidine hydrochloride for injection and 0.9% sodium chloride for injection for Delirium and 2 related conditions. Completed, enrolled 285 participants across 1 site.
Detailed Summary
Postoperative delirium (POD) is a frequently occurring complication after cardiac surgery. Its occurrence is associated with worse outcomes of patients, including increased morbidity, prolonged hospital stay, increased medical cost, and higher mortality. It is also associated with long-term cognitive decline and decreased quality of life. However, until recently, pharmacological interventions that can effectively prevent its occurrence are still limited. The purpose of this study is to investigate whether perioperative dexmedetomidine use can decrease the incidence of postoperative delirium in patients undergoing cardiac surgery.
Study Details
Timeline
Interventions
Before anesthesia, dexmedetomidine hydrochloride for injection (200 ug/2 ml) will be diluted with normal saline to 50 ml (final dexmedetomidine concentration 4 ug/ml). Before the induction of anesthesia, a loading dose will be administered by intravenous infusion at a rate of \[0.9\*kg\] ml/h for 10 minutes (i.e., dexmedetomidine 0.6 μg/kg in 10 minutes), followed by continuous infusion at a rate of \[0.1\*kg\] ml/h (i.e., dexmedetomidine at a rate of 0.4 μg /kg/h) until the end of surgery. At the end of surgery, the infusion rate will be decreased to \[0.025\*kg\] ml/h (i.e., dexmedetomidine at a rate of 0.1 ug/kg/h) and continued until the end of mechanical ventilation after surgery.
Before anesthesia, 0.9% sodium chloride for injection 50 ml will be prepared. Before the induction of anesthesia, a loading dose will be administered by intravenous infusion at a rate of \[0.9\*kg\] ml/h for 10 minutes, followed by continuous infusion at a rate of \[0.1\*kg\] ml/h until the end of surgery. At the end of surgery, the infusion rate will be decreased to \[0.025\*kg\] ml/h and continued until the end of mechanical ventilation after surgery.