At a glance
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Impact of Low-Dose Dexmedetomidine on Sleep Quality in Mechanical Ventilation Patients After Surgery in Intensive Care Unit: a Pilot Randomized, Double-Blind, Placebo-Controlled Trial
In Brief
A Phase 4 clinical trial evaluating Dexmedetomidine and Placebo (normal saline) for Aged and 5 related conditions. Completed, enrolled 80 participants across 1 site.
Detailed Summary
Sleep disturbances frequently occur in intensive care unit (ICU) patients undergoing mechanical ventilation. In a previous study, sedative dose dexmedetomidine (median 0.6 microgram/kg/h) improved sleep quality in mechanically ventilated patients. However, for mechanically ventilated patients, light sedation is better than deep sedation for the outcomes, which is manifested as shortened length of ICU stay, shortened duration of mechanical ventilation, and decreased mortality. In a recent study of the investigators, non-sedative low-dose dexmedetomidine (0.1 microgram/kg/h) improved sleep quality in non-mechanically ventilated elderly patients admitted to the ICU after surgery. The investigators hypothesize that, in mechanically ventilated patients who are admitted to the ICU after surgery, low-dose dexmedetomidine may also improve sleep quality.
Study Details
Timeline
Interventions
Dexmedetomidine is administered as a continuous intravenous infusion at a rate of 0.1-0.2 ug/kg/h (0.025-0.05 ml/kg/h) from study recruitment in the ICU during mechanical ventilation, for no more than 72 hours.
Placebo (normal saline) is administered as a continuous intravenous infusion at a rate of 0.025-0.05 ml/kg/h from study recruitment in the ICU during mechanical ventilation, for no more than 72 hours.