Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep

NCT02856594 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 2016P0007421R01AG053582
• Study Type: interventional
• Target: 469
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Delirium; Sleep; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Incidence of Delirium

  Confusion Assessment Method

  Post operative day 1 (24 hours)

Secondary Outcomes (7)

• ICU Delirium/Coma-free Days

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

• Severity of Delirium

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

• 30-day, 90-day, and 180-day Mortality

  Up to postoperative day 180 (6 months)

• Postoperative Cognitive Status

  30 days, 90 days, and 180 days postoperatively

• Postoperative Health Related Quality of Life

  30 days, 90 days, and 180 days postoperatively

Other Outcomes (1)

• Length of Hospital Stay

  from postoperative day 0 until date of hospital discharge (no prespecified length possible)

Study Arms (2)

Dexmedetomidine-induced sleep

EXPERIMENTAL

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

Drug: Dexmedetomidine

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Dexmedetomidine DRUG

Dexmedetomidine

Also known as: Precedex

Dexmedetomidine-induced sleep

Placebo DRUG

Placebo

Also known as: Normal Saline

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (4)

• 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.

  PMID: 39921932 DERIVED

• 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.

  PMID: 37535937 DERIVED

• 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.

  PMID: 36590787 DERIVED

• 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.

  PMID: 29678977 DERIVED

MeSH Terms

Conditions

Emergence Delirium

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr, Oluwaseun Johson-Akeju
• Organization: Massachusetts General Hospital

oluwaseun.akeju@mgh.harvard.edu

617-724-7200

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Anesthesia

Study Record Dates

• First Submitted: July 29, 2016
• First Posted: August 5, 2016
• Study Start: March 6, 2017
• Primary Completion: February 11, 2022
• Study Completion: February 16, 2022
• Last Updated: March 20, 2023
• Results First Posted: March 20, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Immediately
• Access Criteria: De-identified data and a data dictionary will be made available upon reasonable request to researchers who provide a methodologically sound proposal and whose use of the data has been approved the study authors. Data will be made available immediately following publication, with no anticipated end date, to achieve the aims specified in the approved proposal. Proposals should be directed to oluwaseun.akeju@mgh.harvard.edu.

Locations

US (1)