DeliriumPhase 3MINDDS IINCT06192615
Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS II)
A Phase 3 study testing Intravenous Dexmedetomidine and Sublingual Dexmedetomidine in people with Delirium, run by Massachusetts General Hospital at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Delirium
- What is being tested?
- Intravenous Dexmedetomidine and Sublingual Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,800 participants
- Where
- 14 sitesUnited States
- Study dates
- 6 Jan 2025to 31 Mar 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 60 years or older
- Scheduled to undergo a cardiac surgical procedure with cardiopulmonary bypass
- Planned postoperative admission to the intensive care unit (ICU)
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
United States14 sites, 14 recruiting
- Recruiting
University of Maryland School of Medicine
Baltimore, Maryland, 21201
Patrick Odonkor, MD
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Amit Bardia, MD
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Shahzad Shaefi, MD
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02215
Oluwaseun Johnson-Akeju, MD
- Recruiting
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Charles Hogue, MD
- Recruiting
Duke University Hospital
Durham, North Carolina, 27710
Mihai Podgoreanu, MD
- Recruiting
University of Iowa Carver College of Medicine
Iowa City, Iowa, 522421320
Andrew Feider, MD
- Not yet recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Abirami Kumaresan, MD
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Frederic T Billings, MD
- Recruiting
Columbia University Medical Center
New York, New York, 10032
Vivek Moitra, MD
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Shaun Thompson, MD
- Recruiting
University of California San Francisco
San Francisco, California, 94117
Matthieu Legrand, MD
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Ben Palanca, MD
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
Matthias Eikermann, MD
About this study
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
- Being tested
- Intravenous Dexmedetomidine, Sublingual Dexmedetomidine, Intravenous Placebo, Sublingual Placebo
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous DexmedetomidineDrug
Also called Intravenous Precedex
Intravenous dexmedetomidine (1 μg/kg over 40 minutes, a maximal dose of 80 μg)
Sublingual DexmedetomidineDrug
Also called Sublingual Precedex
Sublingual dexmedetomidine (120 μg)
Intravenous PlaceboDrug
Also called Placebo
Intravenous placebo of 0.9% saline administered over 40 minutes
Sublingual PlaceboDrug
Also called Placebo
Inert sublingual film
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Dexmedetomidine | Experimental | After admission to the ICU and discontinuation of mechanical ventilation, intravenous dexmedetomidine (1 μg/kg over 40 minutes, a maximal dose of 80 μg) and a sublingual placebo (inert film) will be administered nightly for the first three nights while the patient is in the intensive care unit. Receives: Drug: Intravenous Dexmedetomidine; Drug: Sublingual Placebo |
| Sublingual Dexmedetomidine | Experimental | After admission to the ICU and discontinuation of mechanical ventilation, sublingual dexmedetomidine (120 μg) and an intravenous placebo (0.9% saline over 40 minutes) will be administered nightly for the first three nights while the patient is in the intensive care unit. Receives: Drug: Sublingual Dexmedetomidine; Drug: Intravenous Placebo |
| Placebo | Placebo comparator | After admission to the ICU and discontinuation of mechanical ventilation, an intravenous placebo (0.9% saline over 40 minutes) and a sublingual placebo (inert film) will be administered nightly for the first three nights while the patient is in the intensive care unit. Receives: Drug: Intravenous Placebo; Drug: Sublingual Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium
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.
Measured: Postoperative day 1
Secondary outcomes (11)
Delirium
Postoperative delirium will also be assessed as a secondary outcome assessed within the first three days after surgery, and separately within the first seven days following surgery. Delirium will be assessed using the CAM in the same fashion as the primary outcome. In the event the patient is reintubated the CAM-ICU may also be used to assess for postoperative delirium as a secondary outcome.
Measured: Postoperative Day 1 to Day 7
Delirium Severity
Delirium severity will be assessed using the CAM-Severity (CAM-S) within the first three days following surgery, and separately within the first seven days following surgery. The CAM-S ranges from 0 (no delirium features) to 19, with higher scores indicating worsening delirium severity.
Measured: Postoperative day 1 to day 7
Telephonic Montreal Cognitive Assessment
Global cognitive function will be assessed with the T-MoCA in-hospital and at three time points after hospital discharge. Different versions of the T-MOCA will be administered at each time point to minimize learning effects. The T-MoCA ranges from 0 (worst) to 22 (best) points, does not require visual cues or writing, and importantly, can be administered over the phone.
Measured: 30, 180 and 365 days
Global Health
Global health will be assessed at 30, 180 and 365 days using the Patient Reported Outcome Measurement Information System (PROMIS) 29 Profile version 2.1. This assessment results in several subscale scores, each reported as a t-score.
Measured: 30, 180 and 365 days
Pain at Rest and Upon Exertion
Pain will be assessed within the first seven days following surgery, using a trajectory of pain scores at rest and upon exertion/deep breathing. Pain scores will be elicited from patients daily using the Pain Numeric Rating Scale.
Measured: Postoperative day 1 to day 7
Opioid and Analgesic Administration
Outcomes for opioid administration will evaluate the (a) frequency and (b) total consumption, defined as morphine equivalents, in the first 24 and 48 hours postoperatively. These will be captured based off medical record review.
Measured: 48 hours postoperatively
Hospital Length of Stay
Hospital length of stay will be defined as the number of days after surgery until the time of discharge from the hospital.
Measured: Postoperatively until discharge, an average of six days
Intensive Care Unit Length of Stay
Intensive Care Unit (ICU) length of stay will be calculated as the time from discharge from the initial index ICU stay minus the time of admission into the cardiovascular ICU and will be reported in hours.
Measured: Postoperatively until discharge, an average of 24 hours
Readmission
Hospital readmission will be evaluated within the first 30 days postoperatively using the Society for Thoracic Surgery database or via patient report during follow up phone calls.
Measured: 30 days postoperatively
Inpatient Morbidity
Major cardiac events will be evaluated within 30 days postoperatively and include stroke, atrial fibrillation and renal failure. These outcomes will be assessed using the Society for Thoracic Surgery database and medical record review.
Measured: 30 days postoperatively
Mortality
All-cause mortality will be assessed in-hospital and at 30, 180 and 365 days postoperatively. Mortality will be assessed using a combination of electronic medical record review, Society for Thoracic Surgery database, and family report during the follow up phone calls.
Measured: Postoperatively until discharge, an average of six days, and at 30, 180 and 365 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start6 Jan 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oluwaseun Johnson-Akeju, MD, MMSc, Massachusetts General Hospital
- Investigators
- Oluwaseun Johnson-Akeju, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192615
- Sponsor's protocol ID
- 2023P003359
- Acronym
- MINDDS II
- Status last verified
- Sep 2026
- First submitted
- 21 Dec 2023
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS II)
- ClinicalTrials.gov ID
- NCT06192615
- Acronym / sponsor ID
- MINDDS II / 2023P003359
- Conditions
- Delirium
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intravenous Dexmedetomidine | Experimental | Drug: Intravenous Dexmedetomidine, Drug: Sublingual PlaceboAfter admission to the ICU and discontinuation of mechanical ventilation, intravenous dexmedetomidine (1 μg/kg over 40 minutes, a maximal dose of 80 μg) and a sublingual placebo (inert film) will be administered nightly for the first three nights while the patient is in the intensive care unit. |
| Sublingual Dexmedetomidine | Experimental | Drug: Sublingual Dexmedetomidine, Drug: Intravenous PlaceboAfter admission to the ICU and discontinuation of mechanical ventilation, sublingual dexmedetomidine (120 μg) and an intravenous placebo (0.9% saline over 40 minutes) will be administered nightly for the first three nights while the patient is in the intensive care unit. |
| Placebo | Placebo comparator | Drug: Intravenous Placebo, Drug: Sublingual PlaceboAfter admission to the ICU and discontinuation of mechanical ventilation, an intravenous placebo (0.9% saline over 40 minutes) and a sublingual placebo (inert film) will be administered nightly for the first three nights while the patient is in the intensive care unit. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 60 years or older
- Scheduled to undergo a cardiac surgical procedure with cardiopulmonary bypass
- Planned postoperative admission to the intensive care unit (ICU)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous DexmedetomidineAlso: Intravenous PrecedexIntravenous dexmedetomidine (1 μg/kg over 40 minutes, a maximal dose of 80 μg) | Drug | Intravenous Dexmedetomidine |
| Sublingual DexmedetomidineAlso: Sublingual PrecedexSublingual dexmedetomidine (120 μg) | Drug | Sublingual Dexmedetomidine |
| Intravenous PlaceboAlso: PlaceboIntravenous placebo of 0.9% saline administered over 40 minutes | Drug | Placebo, Sublingual Dexmedetomidine |
| Sublingual PlaceboAlso: PlaceboInert sublingual film | Drug | Intravenous Dexmedetomidine, Placebo |
Primary outcome
Delirium
Time frame: Postoperative day 1
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.
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: Yes
Related trials for Delirium
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruitingObservational study
Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study
Emergency Delirium, Postoperative Delirium (POD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oluwaseun Johnson-Akeju, MD principal investigator
Massachusetts General Hospital
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intravenous Dexmedetomidine and Sublingual Dexmedetomidine in people with Delirium, run by Massachusetts General Hospital at 14 sites 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 9 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: looking for participants now, as of the sponsor's last update on 14 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 14 sites 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 phase mean?
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oluwaseun Johnson-Akeju, MD (617-726-3030, ojohnsonakeju@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium (time frame: Postoperative day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2026.