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Recruiting NCT06192615

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

Phase III Interventional Delirium

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intravenous Dexmedetomidine, Sublingual Dexmedetomidine, Intravenous Placebo, Sublingual Placebo.
Who it may be relevant to
Registry conditions: Delirium. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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

Primary outcome measures

  • Delirium [Time frame: Postoperative day 1]
Secondary outcome measures (11)
  • Delirium [Time frame: Postoperative Day 1 to Day 7]
  • Delirium Severity [Time frame: Postoperative day 1 to day 7]
  • Telephonic Montreal Cognitive Assessment [Time frame: 30, 180 and 365 days]
  • Global Health [Time frame: 30, 180 and 365 days]
  • Pain at Rest and Upon Exertion [Time frame: Postoperative day 1 to day 7]
  • Opioid and Analgesic Administration [Time frame: 48 hours postoperatively]
  • Hospital Length of Stay [Time frame: Postoperatively until discharge, an average of six days]
  • Intensive Care Unit Length of Stay [Time frame: Postoperatively until discharge, an average of 24 hours]
  • Readmission [Time frame: 30 days postoperatively]
  • Inpatient Morbidity [Time frame: 30 days postoperatively]
  • Mortality [Time frame: Postoperatively until discharge, an average of six days, and at 30, 180 and 365 days postoperatively]

Eligibility criteria

Inclusion criteria

  • Aged 60 years or older
  • Scheduled to undergo a cardiac surgical procedure with cardiopulmonary bypass
  • Planned postoperative admission to the intensive care unit (ICU)

Exclusion criteria

  • Allergy or hypersensitivity to dexmedetomidine or the placebo study medication
  • Preexisting diagnosis of Alzheimer's Disease or Related Dementia, severe cognitive impairment or delirium at baseline
  • Severe liver failure (Child-Pugh score > 5)
  • Severe deficit(s) due to structural or anoxic brain damage
  • Undergoing a surgical procedure requiring total circulatory arrest
  • SARS-CoV-2 positive or symptomatic (e.g., fever, cough, loss of taste/smell)
  • Blind, deaf, or unable to communicate in English
  • Patients experiencing circumstances for which long-term follow-up might be difficult (e.g., homelessness, active psychotic disorder, or substance abuse)
  • Co-enrollment in other interventional studies that, in the opinion of the site investigator and/or PI, might interfere with study participation, collection, or interpretation of the study data

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

United States · 14 centers
  • Cedars-Sinai Medical Center — Los Angeles
  • University of California San Francisco — San Francisco
  • Northwestern University Feinberg School of Medicine — Chicago
  • University of Iowa Carver College of Medicine — Iowa City
  • University of Maryland School of Medicine — Baltimore
  • Massachusetts General Hospital — Boston
  • Beth Israel Deaconess Medical Center — Boston
  • Brigham and Women's Hospital — Boston
  • … and 6 more centers

Identifiers

NCT: NCT06192615 · 2023P003359

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗