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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
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 belowSelect...
I am scheduled for heart surgery that requires opening my chest, with recovery in the CVICU.
Select...
I am 60 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I can attend all required study visits and complete tests.
Select...
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
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
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).
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Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
671 Previous Clinical Trials
1,564,545 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have allergies or conditions that prevent me from taking dexmedetomidine.I can attend all required study visits and complete tests.I am scheduled for heart surgery that requires opening my chest, with recovery in the CVICU.I am 60 years old or older.You have a significant problem with thinking and memory.I have had aortic arch surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care Group
- Group 2: Dexmedetomidine Hydrochloride Group
Awards:
This trial has 4 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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