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NCT Number: NCT06192615

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.

Recruiting

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cedars-Sinai Medical Center, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous dexmedetomidine

Drug

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

Other names: Intravenous Precedex

Sublingual Dexmedetomidine

Drug

Sublingual dexmedetomidine (120 μg)

Other names: Sublingual Precedex

Intravenous placebo

Drug

Intravenous placebo of 0.9% saline administered over 40 minutes

Other names: Placebo

Sublingual Placebo

Drug

Inert sublingual film

Other names: Placebo

Primary outcomes

  1. 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.

Secondary outcomes

  1. Delirium

    Time frame: Postoperative Day 1 to Day 7

    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.

  2. Delirium Severity

    Time frame: Postoperative day 1 to day 7

    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.

  3. Telephonic Montreal Cognitive Assessment

    Time frame: 30, 180 and 365 days

    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.

  4. Global Health

    Time frame: 30, 180 and 365 days

    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.

  5. Pain at Rest and Upon Exertion

    Time frame: Postoperative day 1 to day 7

    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.

  6. Opioid and Analgesic Administration

    Time frame: 48 hours postoperatively

    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.

  7. Hospital Length of Stay

    Time frame: Postoperatively until discharge, an average of six days

    Hospital length of stay will be defined as the number of days after surgery until the time of discharge from the hospital.

  8. Intensive Care Unit Length of Stay

    Time frame: Postoperatively until discharge, an average of 24 hours

    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.

  9. Readmission

    Time frame: 30 days postoperatively

    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.

  10. Inpatient Morbidity

    Time frame: 30 days postoperatively

    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.

  11. Mortality

    Time frame: Postoperatively until discharge, an average of six days, and at 30, 180 and 365 days postoperatively

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ariel Mueller, MA

CONTACT

[email protected]

6177269252

Oluwaseun Johnson-Akeju, MD

CONTACT

[email protected]

617-726-3030

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Acronym: MINDDS II

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Jan 5, 2024
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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