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NCT06192615 · ClinicalTrials.gov registry record · Phase 3
Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS II)
A Phase 3 study of Delirium, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 1,800
- Enrollment target
- 14
- Study locations
NCT06192615: Recruiting Phase 3 study of Delirium, sponsored by Massachusetts General Hospital.
NCT06192615 is a Phase 3 study of Delirium that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 1,800 participants, above the 859-participant average among 62 other Delirium trials with a reported enrollment target (110% higher). The trial reports 14 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06192615, a Phase 3 study of Delirium, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,800 participants
- Enrollment target
- 14
- Study locations
Study Summary
This is a pragmatic phase III, randomized, blinded, double placebo-controlled, three-arm trial of elderly patients following cardiac surgery to assess the relationship between nighttime intravenous (IV) and sublingual dexmedetomidine on postoperative delirium and functional outcomes after surgery.
Primary Outcome
The primary outcome will be delirium occurring on postoperative day one. Delirium will be assessed using the Confusion Assessment Method (CAM) twice daily. Delirium will be defined as present if either the morning or afternoon assessment are positive for delirium.
Conditions Studied
Interventions
- DRUG Intravenous Dexmedetomidine
- DRUG Sublingual Dexmedetomidine
- DRUG Intravenous Placebo
- DRUG Sublingual Placebo
Study Locations (14)
Massachusetts
- Massachusetts General Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
- Brigham and Women's Hospital - Boston
California
- Cedars-Sinai Medical Center - Los Angeles
- University of California San Francisco - San Francisco
New York
- Columbia University Medical Center - New York
- Montefiore Medical Center - The Bronx
Illinois
- Northwestern University Feinberg School of Medicine - Chicago
Iowa
- University of Iowa Carver College of Medicine - Iowa City
Maryland
- University of Maryland School of Medicine - Baltimore
Missouri
- Washington University School of Medicine - St Louis
Nebraska
- University of Nebraska Medical Center - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,800 participants |
| Start Date | 2025-01-06 |
| Est. Completion | 2029-03-31 |
| Phase | Phase 3 |
What NCT06192615 shows while recruiting
NCT06192615 is an interventional study that assigns participants to a tested intervention. Its 1,800 participants enrollment target places it among the larger protocols in the corpus, above the 859-participant average among 62 other Delirium trials with a reported enrollment target (110% higher).
The record links to 1 condition, with Delirium appearing as the primary indexed condition, and to 4 interventions - of which Intravenous Dexmedetomidine is the first listed.
NCT06192615 lists 14 locations in 10 states (Massachusetts, California, New York).
Frequently Asked Questions
What is clinical trial NCT06192615 about?
NCT06192615 is a clinical study titled "Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS II)". This is a pragmatic phase III, randomized, blinded, double placebo-controlled, three-arm trial of elderly patients following cardiac surgery to assess the relationship between nighttime intravenous (IV) and sublingual dexmedetomidine on postoperative delirium and functional outcomes after surgery.
What is the current status of trial NCT06192615?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,800 participants. The study started on 2025-01-06. Estimated completion is 2029-03-31.
What conditions does trial NCT06192615 study?
This clinical trial studies the following conditions: Delirium.
What interventions are being tested in trial NCT06192615?
The interventions under investigation include: Intravenous Dexmedetomidine (DRUG), Sublingual Dexmedetomidine (DRUG), Intravenous Placebo (DRUG), Sublingual Placebo (DRUG).
Who is sponsoring clinical trial NCT06192615?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06192615 being conducted?
This trial has 14 study locations across California, Illinois, Iowa, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Delirium
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06192615's enrollment target sits among peer trials
1,800 5th of 62 higher than 58 of 62 other Delirium trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Delirium trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Mitigating Delirium With Fluvoxamine Treatment for Non-Cardiac Surgery
RECRUITING · Phase 3
-
Goal-Directed Sedation in Mechanically Ventilated Infants and Children
RECRUITING · Phase 3
-
PANDORA: Delirium Prevention After Cardiac Surgery Using IV Acetaminophen to Prevent Postoperative Delirium in Older Cardiac Surgical Patients
ACTIVE NOT RECRUITING · Phase 3
-
The MENDS2 Study, Maximizing the Efficacy of Sedation and Reducing Neurological Dysfunction and Mortality in Septic Patients With Acute Respiratory Failure
COMPLETED · Phase 3
-
The Modifying the Impact of ICU-Associated Neurological Dysfunction-USA (MIND-USA) Study
COMPLETED · Phase 3
-
Researching Efficient Approaches to Delirium Identification-Sustaining Effective Translation
RECRUITING · NA
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