Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep

• Status: Active, not recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: National Institute on Aging (NIA); National Institutes of Health (NIH)
• Treatments: Dexmedetomidine

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