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Postoperative DeliriumPhase 2/3MINDDSNCT02856594

Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep

A Phase 2/3 study testing Dexmedetomidine in people with Postoperative Delirium and Sleep, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Postoperative Delirium, Sleep, Anesthesia
What is being tested?
Dexmedetomidine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
469 participants
Where
1 siteUnited States
Study dates
6 Mar 2017to 16 Feb 2022
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age ≥ 60
  • Scheduled for a cardiac surgical procedure with planned post-operative admission to the CSICU for ≥ 24 hours
  • Scheduled same day surgical admission

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS): A Randomized Placebo-controlled Trial

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.

Read the detailed description

Delirium is an acute brain dysfunction characterized by disturbances in attention, awareness, and cognition not explained by a preexisting neurocognitive disorder. Although the increased mortality rates ascribed to delirium remain debatable, delirium remains a leading cause of preventable morbidity in hospitalized elderly patients. It is also associated with prolonged hospitalization, prolonged institutionalization, and long-term cognitive deficits. Patients with pre-existing dementia, such as Alzheimer's disease, are especially vulnerable to developing delirium. The total healthcare cost attributable to delirium is estimated between $143 and $152 billion annually. In the United States, delirium occurs in approximately 80% of critically ill patients admitted to medical/surgical intensive care units (ICU), and 15% of patients admitted to cardiac surgical (CS) ICU. Most patients diagnosed with delirium also present with multiple comorbidities (sepsis, multi-organ failure) that significantly confound our understanding of this disease. Thus, to date, no pharmacological intervention to treat delirium has been identified.

There is mounting evidence to suggest that sleep deprivation may be a modifiable risk factor for the development of delirium. Presently, pharmacological treatment with no current medication (benzodiazepines, antipsychotics) induces natural sleep or reliably reduces the incidence of delirium. The investigators have found that biomimetic sleep, defined here as pharmacological induction of rapid eye movement sleep (REM) and non-REM (N1, N2, N3) sleep states using dexmedetomidine, can now be achieved in humans. The overall objective of this study is to evaluate the efficacy of biomimetic sleep in reducing the incidence and severity of delirium in extubated CSICU patients. The investigators will also assess for peri-operative electroencephalogram biomarkers of delirium, and the association between delirium and chronic neuroinflammation using positron emission tomography. The MINDDS study is poised to enable therapeutic and diagnostic discoveries to aid the care of elderly patients who are at risk for developing postoperative delirium.

Being tested
Dexmedetomidine, Placebo
Medical subject headings
Emergence Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexmedetomidineDrug

    Also called Precedex

    Dexmedetomidine

  • PlaceboDrug

    Also called Normal Saline

    Placebo

Study groups in NCT02856594
Study groupRoleWhat they receive
Dexmedetomidine-induced sleepExperimentalPrecedex (Dexmedetomidine) intervention: Intravenous administration of 1mcg/kg over 40 minutes.
Receives: Drug: Dexmedetomidine
PlaceboPlacebo comparatorPlacebo of normal saline: Intravenous administration of normal saline over 40 minutes.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Delirium

    The number of patients with delirium is reported using the Confusion Assessment Method.

    Measured: Post operative day 1 (24 hours)

Secondary outcomes (7)

  1. ICU Delirium/Coma-free Days

    Confusion Assessment Method

    Measured: Up until postoperative day 3, or up until postoperative day 7 or discharge for patients who are delirious beyond postoperative day 5

  2. Severity of Delirium

    Confusion Assessment Method (CAM): Minimum Score=0, Maximum Score=19, Higher Scores: indicate increased severity of delirium

    Measured: Up until postoperative day 3, or up until postoperative day 7 or discharge for patients who are delirious beyond postoperative day 5

  3. Cumulative 30-day, 90-day, and 180-day Mortality

    The number of cumulative deaths occurring at 30-days, 90-days, and 180-days

    Measured: Up to postoperative day 180 (6 months)

  4. Postoperative Cognitive Status

    Telephone Montreal Cognitive Assessment (tMoCA): Minimum Score=0, Maximum Score=22, Higher Scores: indicate better cognitive function

    Measured: 30 days, 90 days, and 180 days postoperatively

  5. Postoperative Health Related Quality of Life

    This included the PROMIS Global Health SF V.1.1, PROMIS Physical Function SF 8b V.1.2, PROMIS Pain Interference SF 8a V.1.0, PROMIS Applied Cognition Abilities SF 8a V.1.0, and PROMIS Sleep Disturbance SF 4A V.1.0, respectively. Scores from each assessment were converted to a T-score for analysis with a mean of 50 and a standard deviation of 10, with lower scores on the PROMIS Pain Interference SF and PROMIS Sleep Disturbance SF considered better, whereas higher scores on all other assessments were considered better.

    Measured: 30 days, 90 days, and 180 days postoperatively

  6. Blood Delirium Biomarkers

    Blood samples will be taken including whole blood, serum, TruCulture, and PAXgene to assess proteins, DNA, and RNA.

    Measured: perioperative

  7. EEG Delirium Biomarkers

    EEG alpha power will be analyzed for association with delirium.

    Measured: intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2016 (estimated)
  2. Study start6 Mar 2017
  3. Primary completion11 Feb 2022
  4. Study completion16 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
469 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02856594
Sponsor's protocol ID
2016P000742
Other IDs
1R01AG053582
Acronym
MINDDS
Status last verified
Aug 2026
First submitted
29 Jul 2016
Last updated
1 Sep 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Freedman IG, Boncompte G, Qu JZ, Khawaja ZQ, Turco I, Mueller A, Wiredu K, McKay TB, Westover MB, Pedemonte JC, Akeju O. Anesthesia-induced electroencephalogram oscillations and perioperative outcomes in older adults undergoing cardiac surgery. J Clin Anesth. 2025 Mar;102:111770. doi: 10.1016/j.jclinane.2025.111770. Epub 2025 Feb 7.

    PubMed 39921932

  • Wiredu K, Mueller A, McKay TB, Behera A, Shaefi S, Akeju O. Sex Differences in the Incidence of Postoperative Delirium after Cardiac Surgery: A Pooled Analyses of Clinical Trials. Anesthesiology. 2023 Oct 1;139(4):540-542. doi: 10.1097/ALN.0000000000004656. No abstract available.

    PubMed 37535937

  • Qu JZ, Mueller A, McKay TB, Westover MB, Shelton KT, Shaefi S, D'Alessandro DA, Berra L, Brown EN, Houle TT, Akeju O; MINDDS Study Team. Nighttime dexmedetomidine for delirium prevention in non-mechanically ventilated patients after cardiac surgery (MINDDS): A single-centre, parallel-arm, randomised, placebo-controlled superiority trial. EClinicalMedicine. 2022 Dec 24;56:101796. doi: 10.1016/j.eclinm.2022.101796. eCollection 2023 Feb.

    PubMed 36590787

  • Shelton KT, Qu J, Bilotta F, Brown EN, Cudemus G, D'Alessandro DA, Deng H, DiBiasio A, Gitlin JA, Hahm EY, Hobbs LE, Houle TT, Ibala R, Loggia ML, Pavone KJ, Shaefi S, Tolis G, Westover MB, Akeju O. Minimizing ICU Neurological Dysfunction with Dexmedetomidine-induced Sleep (MINDDS): protocol for a randomised, double-blind, parallel-arm, placebo-controlled trial. BMJ Open. 2018 Apr 20;8(4):e020316. doi: 10.1136/bmjopen-2017-020316.

    PubMed 29678977

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Dexmedetomidine in people with Postoperative Delirium and Sleep, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Delirium (time frame: Post operative day 1 (24 hours)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02856594, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.

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MINDDS Clinical Trial NCT02856594 | AzTrials