MedTrace Logo

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

NCT06192615 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1800

Last updated 2025-12-31

No results posted yet for this 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

  • Delirium

Interventions

DRUG

Intravenous Dexmedetomidine

Intravenous dexmedetomidine (1 μg/kg over 40 minutes, a maximal dose of 80 μg)

DRUG

Sublingual Dexmedetomidine

Sublingual dexmedetomidine (120 μg)

DRUG

Intravenous Placebo

Intravenous placebo of 0.9% saline administered over 40 minutes

DRUG

Sublingual Placebo

Inert sublingual film

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Oluwaseun Johnson-Akeju, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-06
Primary Completion
2027-10-31
Completion
2029-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06192615 on ClinicalTrials.gov