Phase 3 N=469 Randomized Quadruple-blind Treatment

Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep

Postoperative Delirium · Sleep · Anesthesia

Bottom Line

View on ClinicalTrials.gov: NCT02856594 ↗

Enrolled (actual)

469

Serious AEs

0.0%

Results posted

Mar 2023

Primary outcome: Primary: Incidence of Delirium — 5; 16 Participants — p=0.029

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Dexmedetomidine (Drug); Placebo (Drug)
Age: Adult, Older Adult · 60+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: Feb 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of Delirium	5; 16	0.029 sig
SECONDARY ICU Delirium/Coma-free Days	0; 2; 6; 7; 8; 16	—
SECONDARY Severity of Delirium	3.0; 3.0	0.24
SECONDARY 30-day, 90-day, and 180-day Mortality	3; 1; 3; 1; 4; 1	—
SECONDARY Postoperative Cognitive Status	20.0; 20.0; 20.0; 20.0; 20.0; 21.0	—
SECONDARY Postoperative Health Related Quality of Life	50.8; 47.7; 54.1; 54.1; 57.7; 54.1	—
SECONDARY Blood Delirium Biomarkers	—	—
SECONDARY EEG Delirium Biomarkers	—	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02856594). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.