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Alpha-2 Adrenergic Agonist

Dexmedetomidine for Postoperative Cognitive Dysfunction (CODEX Trial)

Phase 4

Recruiting

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

Age ≥60

Must not have

Allergy/contraindication to dexmedetomidine (untreated 2nd degree type 2 or 3rd degree heart block (pacemaker), cirrhosis, HR < 50 , grade 4 LV, renal failure or on renal replacement therapy)

Aortic arch replacement/re-implantation (Bentalls)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3, 6, 12 months

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial is testing whether the drug Dexmedetomidine can prevent postoperative cognitive dysfunction (POCD), which is when patients have trouble thinking and remembering after surgery.

Who is the study for?

This trial is for cardiac surgery patients aged 60 or older who are recovering in the CVICU and can complete cognitive tests post-surgery. It's not for those with major pre-op cognitive issues, certain heart conditions, severe liver or kidney disease, or an allergy to dexmedetomidine.

What is being tested?

The study is testing whether Dexmedetomidine (DEX) can prevent long-term memory and thinking problems after cardiac surgery. The goal is to see if DEX improves recovery and reduces hospital stay and healthcare costs.

What are the potential side effects?

Possible side effects of Dexmedetomidine may include slow heart rate, low blood pressure, dry mouth, nausea. In rare cases it might cause serious allergic reactions.

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 initial 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 do not have severe allergies or conditions that dexmedetomidine could worsen.

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I have had an aortic arch replacement or Bentall procedure.

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I can attend all required study visits and complete tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 6, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3, 6, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, 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

Post-operative cognitive dysfunction

Secondary study objectives

Delirium

Depressive symptoms

In-hospital mortality for index surgery

+7 more

Awards & Highlights

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.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Active Control

Group I: Dexmedetomidine Hydrochloride GroupActive Control1 Intervention

Patients will receive a loading dose of 1.2 μg/kg dexmedetomidine prior to transfer to CVICU over 20 min immediately postoperative, followed by continuous infusion of 0.3 μg/kg/h for up to 12 hours or until patient is ready for discharge from CVICU (whichever is earlier). Any additional sedatives necessary at the discretion of ICU.

Group II: Standard of Care GroupActive Control1 Intervention

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

0 / 5Eligibility criteria met