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Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients

ConditionsDeliriumCognitive DysfunctionCognition DisorderNeurocognitive DisordersMental DisordersConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsDexmedetomidineHypnotics and SedativesCentral Nervous System DepressantsPhysiological Effects of DrugsAnalgesics, Non-NarcoticAnalgesicsMolecular Mechanisms of Pharmacological Action
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age60+
SponsorSunnybrook Health Sciences Centre

About this trial

Anesthesia is a drug induced, reversible, comatose state that facilitates surgery and it is widely assumed that cognition returns to baseline after anesthetics have been eliminated. However, many patients have persistent memory impairment for weeks to months after surgery. Cardiac surgery appears to carry the highest risk of postoperative cognitive dysfunction (POCD). These cognitive deficits are associated with increased mortality, prolonged hospital stay and loss of independence. The investigators propose to investigate the role of Dexmedetomidine (DEX) in preventing long-term POCD after cardiac surgery and enhancing early postoperative recovery. It is anticipated that DEX will be the first effective preventative therapy for POCD, improve patient outcomes, and reduce length of stay and healthcare costs.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Age ≥60

Disqualifiers

Lack of patient consent

Pre-operative major cognitive dysfunction (CogState Brief Battery score < 80) at screening

Aortic arch replacement/re-implantation (surgery requiring hypothermic circulatory arrest, e.g. Bentall procedure)

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexmedetomidine Hydrochloride Group

    Drug

    Dexmedetomidine will be initiated prior to transfer to the CVICU with loading dose of 1.2 ug/kg over approximately 20-60 minutes. This will be followed by an infusion at 0.3 ug/kg/h in CVICU for up to 12 hours from the time DEX infusion started or until the patient is ready for discharge from the CVICU (whichever is earlier). Any additional sedatives necessary at the discretion of ICU.

Treatment groups

2,400 Participants
are divided into 2 treatment groups
Group A: Dexmedetomidine Hydrochloride GroupActive comparator 1 intervention
Group B: Standard of Care GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Post-operative cognitive dysfunction

Presence of POCD assessed by CogState Brief Battery (CBB)

Time frame
3 months

Secondary outcomes

1

Post-operative cognitive dysfunction (POCD) at 1 week, 6 months, 12 months after surgery

POCD assessed by CogState Brief Battery (CBB)

Time frame
1 week, 6 and 12 months
2

Delirium

Confusion Assessment Method (CAM/CAM-ICU) or Intensive Care Delirium Screening Checklist (ICDSC), binary scale to determine if delirium is present or absent

Time frame
Anytime up to post-operative day 10
3

Length of stay

ICU and total hospital stay

Time frame
An average of 5 -14 days
4

Depressive symptoms

Evaluated by PHQ-9 (Patient Health Questionnaire, scale 0-27, higher score is worse outcome)

Time frame
3, 6, and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sunnybrook Health Sciences Centre

Lead sponsor

London Health Sciences Centre

Collaborator

University Health Network, Toronto

Collaborator

McMaster University

Collaborator

Canadian Institutes of Health Research (CIHR)

Collaborator

The Dana Foundation

Collaborator

Brain Canada

Collaborator

Alzheimer's Association

Collaborator

Hamilton Health Sciences Corporation

Collaborator

University of Saskatchewan

Collaborator

Fraser Health

Collaborator

Providence Health & Services

Collaborator

Source ClinicalTrials.gov
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