Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep

Description

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.

Study Start Date

March, 06 2017

Estimated Completion Date

June 2020

Interventions

  • Drug: Dexmedetomidine
  • Drug: Placebo

Study ID

Massachusetts General Hospital -- 2016P000742

Status

Recruiting

Trial ID

NCT02856594

Study Type

Interventional

Trial Phase

Phase 2/Phase 3

Enrollment Quota

300

Sponsor

Massachusetts General Hospital

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

Gender

All

Ages

60 Years and older

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Oluwaseun JohnsonAkeju MDMMSc 617-724-7200 ojohnsonakeju@partners.org

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