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RECRUITING Phase 3

Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS II)

NCT06192615 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 1,800 participants
Start Date 2025-01-06
Est. Completion 2029-03-31
Phase Phase 3

Sponsor

Massachusetts General Hospital

1,948 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06192615

The ClinicalTrials.gov registry entry for NCT06192615 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,800 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 1,948 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06192615 reports 14 study locations spanning 10 distinct geographic areas — top geographies include Massachusetts, California, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06192615?

This trial is sponsored by Massachusetts General Hospital, which has 1,948 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial