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Alpha-2 Adrenergic Agonist

Dexmedetomidine for Postoperative Cognitive Dysfunction

Phase 4

Waitlist Available

Led By Stephen Choi, MD,MSc,FRCPC

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

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

Must have

Planned CABG (including off-pump) or valve replacement (+/- CABG) via sternotomy/thoracotomy, with initial recovery in the Cardiovascular Intensive Care Unit (CVICU)

Age ≥60

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial will investigate whether the drug Dexmedetomidine can prevent long-term cognitive impairment after cardiac surgery.

Who is the study for?

This trial is for individuals aged 60 or older who are scheduled for open heart surgery (CABG or valve replacement) and will recover in the CVICU. They must not have severe pre-existing cognitive issues, a history of certain heart conditions, liver cirrhosis, very slow heartbeat, advanced kidney disease, or be unable to attend follow-up assessments.Check my eligibility

What is being tested?

The study is testing whether Dexmedetomidine (DEX), given during cardiac surgery, can prevent long-term memory and thinking problems that sometimes occur after such operations. The goal is to see if DEX improves recovery and reduces hospital stays and healthcare costs.See study design

What are the potential side effects?

Potential side effects of Dexmedetomidine may include slowed heart rate, low blood pressure, dry mouth, nausea. It's important to note that patients with specific heart conditions or other health issues were excluded due to higher risk of side effects.

Eligibility Criteria

Inclusion Criteria

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

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I am scheduled for heart surgery that requires opening my chest, with recovery in the CVICU.

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I am 60 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Rate of recruitment

Secondary outcome measures

Completion of follow-up assessments

Trial Design

2Treatment groups

Active Control

Group I: Standard of Care GroupActive Control1 Intervention

Standard sedation protocols will be followed at the discretion of the attending physician.

Group II: Dexmedetomidine Hydrochloride GroupActive Control1 Intervention

Patients will receive a loading dose of 1 μg/kg dexmedetomidine prior to transfer to CVICU over 20 min immediately postoperative, followed by continuous infusion of 0.1- 1.0 μg/kg/h for up to 24 hours or until patient is ready for discharge from CVICU (whichever is earlier).

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor

656 Previous Clinical Trials

1,550,532 Total Patients Enrolled

Stephen Choi, MD,MSc,FRCPCPrincipal InvestigatorSunnybrook Health Sciences Centre

1 Previous Clinical Trials

2,400 Total Patients Enrolled

Sinziana Avramescu, MD,PhD,FRCPCPrincipal InvestigatorSunnybrook Health Sciences Centre

Media Library

Dexmedetomidine (Alpha-2 Adrenergic Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT03480061 — Phase 4

Postoperative Cognitive Dysfunction Research Study Groups: Standard of Care Group, Dexmedetomidine Hydrochloride Group

Postoperative Cognitive Dysfunction Clinical Trial 2023: Dexmedetomidine Highlights & Side Effects. Trial Name: NCT03480061 — Phase 4

Dexmedetomidine (Alpha-2 Adrenergic Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03480061 — Phase 4

Frequently Asked Questions

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

Are there any extant experiments involving the Dexmedetomidine Hydrochloride Group?

"Presently, there are 110 clinical studies exploring the benefits of Dexmedetomidine Hydrochloride Group with 23 trials occurring in Phase 3. The bulk of these analyses take place in Karachi, Sindh but research sites for this medicated group span a total of 207 locations worldwide."

Answered by AI

What conditions have been alleviated with Dexmedetomidine Hydrochloride Group?

"Dexmedetomidine Hydrochloride Group is employed to combat a variety of ailments, including mechanical ventilations, cyclic vomiting syndrome, and intubation."

Answered by AI

What is the scale of this clinical experiment?

"This investigation has wrapped up its recruitment process and is no longer searching for participants. It was originally posted on August 9th, 2018 before being updated last on September 12th 2022. However, if you are interested in clinical trials related to delirium or Dexmedetomidine Hydrochloride Group there are 1875 and 110 studies actively recruiting respectively."

Answered by AI

Has the Food and Drug Administration deemed Dexmedetomidine Hydrochloride Group safe for public use?

"Due to its Phase 4 status, which denotes the drug's approval by regulatory authorities, Dexmedetomidine Hydrochloride Group has been scored a 3 for safety."

Answered by AI

Does this investigation currently accept participants?

"According to the clinicaltrials.gov database, this particular trial is not recruiting new participants at present. It was initially listed on August 9th 2018 but has not been updated since September 12th 2022. Nevertheless, 1985 other medical trials have open slots for enrollment currently available."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dexmedetomidine to Reduce the Incidence of POCD After Open Cardiac Surgery

2018. "Dexmedetomidine to Reduce the Incidence of POCD After Open Cardiac Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03480061.

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