Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

469 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-06

Study Completion Date

2022-02-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT06192615

Delirium

RECRUITING PHASE3

Dexmedetomidine and Outcomes of Elderly Admitted to ICU After Surgery

NCT04204798

Elderly Surgery Intensive Care Unit +2 more

ACTIVE_NOT_RECRUITING NA

Effect of Dexmedetomidine Upon Sleep Postoperatively

NCT00333632

Sleep

WITHDRAWN PHASE4

Does Nightly Dexmedetomidine Improve Sleep and Reduce Delirium in ICU Patients?

NCT01791296

Sleep Deprivation Delirium

COMPLETED PHASE4

Reducing Days DELirious With DEXmedetomidine as Part of an Intensive Care Unit Sleep Promotion Bundle

NCT06824077

Sleep Delirium ICU Hospitalization

NOT_YET_RECRUITING EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Delirium Sleep Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dexmedetomidine-induced sleep

Precedex (Dexmedetomidine) intervention: Intravenous administration of 1mcg/kg over 40 minutes.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Dexmedetomidine

Placebo

Placebo of normal saline: Intravenous administration of normal saline over 40 minutes.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dexmedetomidine

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Precedex Normal Saline

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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
* 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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes