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

University Health Network, Toronto

Status: Completed

Conditions: Delirium; Cardiac Disease

Treatments: Drug: Dexmedetomidine; Drug: Propofol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01378741

UHN10-0771A

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 185 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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185 participants in 2 patient groups

Propofol

Active Comparator group

Description:

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

Treatment:

Drug: Propofol

Dexmedetomidine

Active Comparator group

Description:

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.

Treatment:

Drug: Dexmedetomidine