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Intravenous Dexmedetomidine for Delirium (MINDDS II Trial)

Phase 3

Waitlist Available

Led By Oluwaseun Johnson-Akeju, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 60 years or older

Scheduled to undergo a cardiac surgical procedure with cardiopulmonary bypass

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30, 180 and 365 days

Awards & highlights

MINDDS II Trial Summary

This trial is testing the effects of two different ways of giving a medication called dexmedetomidine to older patients who have had heart surgery. The trial will look at how the medication given through an

Who is the study for?

This trial is for elderly patients who have recently undergone cardiac surgery and are at risk of developing delirium, a common postoperative complication. Participants must meet certain health standards to be eligible.Check my eligibility

What is being tested?

The MINDDS II study is testing whether dexmedetomidine, given either intravenously or sublingually at night, can reduce the incidence of delirium and improve recovery after heart surgery compared to placebo.See study design

What are the potential side effects?

Dexmedetomidine may cause side effects such as low blood pressure, slow heart rate, dry mouth, and drowsiness. These are generally mild but can vary from person to person.

MINDDS II Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 60 years old or older.

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I am scheduled for heart surgery that will use a heart-lung machine.

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I am scheduled to stay in the ICU after my surgery.

MINDDS II Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30, 180 and 365 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30, 180 and 365 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30, 180 and 365 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Delirium

Delirium Severity

Global Health

+8 more

MINDDS II Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Sublingual DexmedetomidineExperimental Treatment2 Interventions

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.

Group II: Intravenous DexmedetomidineExperimental Treatment2 Interventions

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.

Group III: PlaceboPlacebo Group2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sublingual Dexmedetomidine

2019

Completed Phase 3

~50

Intravenous Placebo

2016

Completed Phase 3

~2150

Intravenous Dexmedetomidine

2023

Completed Phase 4

~150

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,936 Previous Clinical Trials

13,196,956 Total Patients Enrolled

7 Trials studying Delirium

1,704 Patients Enrolled for Delirium

Oluwaseun Johnson-Akeju, MDPrincipal InvestigatorMassachusetts General Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many distinct locations is this investigation currently being conducted?

"This clinical trial is currently underway at 12 different locations, including the Bronx, Baltimore, and Chicago. It is highly recommended that participants choose a clinic nearest to them in order to minimize travel requirements if they decide to enroll."

Answered by AI

Are patients currently being actively enrolled in this ongoing medical study?

"According to the details available on clinicaltrials.gov, this trial is not currently accepting new participants. The study was initially posted on April 1st, 2024 and last updated on December 21st, 2023. However, it's worth noting that there are currently 135 other ongoing studies actively seeking eligible candidates for participation."

Answered by AI

To what extent does intravenous administration of dexmedetomidine pose a risk to patients?

"Based on the classification of this trial as Phase 3, our team at Power rates the safety of Intravenous Dexmedetomidine as a 3. This rating indicates that there is existing evidence supporting its efficacy and multiple rounds of data confirming its safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Oluwaseun Johnson-Akeju, MD, MMSc 2024. "Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS II)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06192615.