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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

Must not have

Unlikely to comply with study assessments (e.g. no fixed address, cannot complete cognitive tests at the 3, 6, and 12 month timepoints)

Aortic arch replacement/re-implantation (Bentalls)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Pivotal Trial

Drug Has Already Been Approved

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I can attend all required study visits and complete tests.

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I have had aortic arch surgery.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of recruitment

Secondary study objectives

Completion of follow-up assessments

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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 / 4Eligibility criteria met