Low-dose Dexmedetomidine and Postoperative Delirium After Cardiac Surgery (NCT03624595) | Clinical Trial Compass
CompletedNot Applicable
Low-dose Dexmedetomidine and Postoperative Delirium After Cardiac Surgery
China504 participantsStarted 2019-04-16
Plain-language summary
Delirium is an acutely occurred and fluctuating cerebral dysfunction characterized with inattention, altered consciousness, cognitive decline and/or abnormal perception. It is common in the elderly after cardiac surgery and is associated with worse outcomes. Causes leading to delirium are multifactorial but sleep disturbances remains an important one. In previous studies, sedative-dose dexmedetomidine improves sleep quality in ICU patients with mechanical ventilation; and low-dose dexmedetomidine improves sleep quality in postoperative patients without mechanical ventilation. In recent studies of elderly after noncardiac surgery, night-time infusion of low-dose dexmedetomidine reduces delirium and improves 2-year survival. The investigators hypothesize that, for elderly patients after cardiac surgery, night-time infusion of dexmedetomidine may also improve sleep quality, reduce delirium development and improve 2-year survival.
Who can participate
Age range60 Years – 90 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥60 years but \<90 years;
✓. Scheduled to undergo cardiac surgery with cardiopulmonary bypass under general anesthesia;
✓. Expected to stay in the intensive care unit (ICU) for at least 1 night after surgery.
Exclusion criteria
✕. Refuse to participate in the study;
✕. Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis;
✕. Preoperative obstructive sleep apnea (previously diagnosed as obstructive sleep apnea, or the snoring, tiredness, observed apnea, high blood pressure-body mass index, age, neck circumference and gender \[STOP-Bang\] questionnaires ≥3);
✕. Inability to communicate during the preoperative period because of coma, profound dementia or language barrier;
✕. Preoperative sick sinus syndrome, severe sinus bradycardia (\< 50 beats per minute), or second-degree atrioventricular block or above without pacemaker;
✕
What they're measuring
1
Incidence of delirium within the first 5 days after surgery