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NCT Number: NCT01378741

Reducing Delirium After Cardiac Surgery: A Multifaceted Approach Of Perioperative Care

The objective of this study is to reduce the incidence of postoperative delirium after cardiac surgery in the elderly patient. This proposal is a clinical trial designed to reduce delirium in patients undergoing cardiac surgery by replacing standard postoperative sedation protocols (propofol, midazolam, opioids) with a new alpha2-adrenergic receptor agonist (dexmedetomidine) possessing sedative, analgesic, and antinociceptive properties. Resource utilization analysis will be performed to determine cost effectiveness of the new treatment modality.

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Key information

Conditions

Delirium Cardiac Disease Cardiovascular Diseases Confusion Heart Diseases Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

About this study

The proposed study will be a prospective, randomized, open label study comparing multimodal protocols for postoperative sedation after cardiac surgery. Patients will be randomly allocated to either dexmedetomidine or propofol (control) groups according to a computer generated randomization code in predetermined size blocks of four.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥60 years, undergoing high risk cardiac surgery, signed informed consent.

Exclusion criteria

  • Patients with symptomatic cerebrovascular disease, history of delirium, schizophrenia or preoperative use of psychotropic medications.

Treatment and study plan

Propofol

Drug

Upon arrival to ICU patients will receive a propofol 2-6mg/kg infusion until tracheal extubation

Other names: Diprivan

Dexmedetomidine

Drug

Upon arrival to ICU patients will receive dexmedetomidine bolus of 0.4mcg/kg followed by an infusion of 0.2-0.7mcg/kg per hour for a maximum period of 24 hours.

Other names: Precedex

Primary outcomes

  1. Dichotomous outcome, a number of patients with delirium in the two study groups.

    Time frame: up to 7 days postoperatively or discharge

    Assessment of delirium will be performed utilizing the CAM-ICU

Secondary outcomes

  1. The total cost for each patient

    Time frame: Up to 7 days or discharge

    Summation of direct-variable, direct-fixed, and overhead costs

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Hospira, now a wholly owned subsidiary of Pfizer

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Jun 22, 2011
Registry last updated
Apr 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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