Phase 3
Completed N=469
Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep
Postoperative Delirium · Sleep · Anesthesia
Source: ClinicalTrials.gov NCT02856594 ↗
Enrolled (actual)
469
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcomePrimary: Incidence of Delirium — 5; 16 Participants — p=0.029
◆ Published Evidence
Established
64citations · ~21 / year
Nighttime dexmedetomidine for delirium prevention in non-mechanically ventilated patients after cardiac surgery (MINDDS): A single-centre, parallel-arm, randomised, placebo-controlled superiority trial.
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.
Linked Publications (4)
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Nighttime dexmedetomidine for delirium prevention in non-mechanically ventilated patients after cardiac surgery (MINDDS): A single-centre, parallel-arm, randomised, placebo-controlled superiority trial.
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Minimizing ICU Neurological Dysfunction with Dexmedetomidine-induced Sleep (MINDDS): protocol for a randomised, double-blind, parallel-arm, placebo-controlled trial.
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Sex Differences in the Incidence of Postoperative Delirium after Cardiac Surgery: A Pooled Analyses of Clinical Trials.
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Anesthesia-induced electroencephalogram oscillations and perioperative outcomes in older adults undergoing cardiac surgery.
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 |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT02856594) and the linked publication. 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. Informational only — not medical advice.