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Completed
NCT02856594
Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep
Conditions: Postoperative Delirium, Sleep, Anesthesia
Sex: All
Ages: 60 Years – N/A
Healthy volunteers: Yes
Phase: PHASE2, PHASE3
Enrollment: 469
Sponsor: Massachusetts General Hospital
Location: Massachusetts General Hospital Boston Massachusetts
Summary
This study aims to determine whether, compared with placebo, the nighttime administration of a intravenous dexmedetomidine is effective at inducing sleep and preventing postoperative delirium in extubated post-cardiac surgical patients.
Eligibility Criteria
Inclusion Criteria:
* Age ≥ 60
* Scheduled for a cardiac surgical procedure with planned post-operative admission to the CSICU for ≥ 24 hours
* Scheduled same day surgical admission
Exclusion Criteria:
* Blind, deafness or the inability to speak English
* Greater than 2 days of ICU admission in the month preceding the current surgical procedure
* Renal and liver failure requiring dialysis or Child-Pugh score \> 5
* Follow-up difficulties (i.e. active substance abuse, psychotic disorder, homelessness)
* Previous cardiac surgery within 1 year of surgical procedure
* Allergy to dexmedetomidine
* Chronic therapy with benzodiazepines and/or antipsychotics
* Severe deficit due to structural or anoxic brain damage
* Surgical procedure requiring total circulatory arrest
Objective Drop Criteria
* Scheduled for a second surgical procedure during hospital stay
* Post-operative intubation \> 12 hours
Source: ClinicalTrials.gov (NCT02856594). StuddyBuddy aggregates publicly available trial information.