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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01378741

Enrollment

185

Registered

2011-06-22

Start date

2011-04-30

Completion date

2015-04-30

Last updated

2015-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Disease, Delirium

Keywords

delirium, cardiac surgery, postoperative sedation

Brief summary

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.

Detailed 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.

Interventions

DRUGPropofol

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

DRUGDexmedetomidine

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.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Dichotomous outcome, a number of patients with delirium in the two study groups.	up to 7 days postoperatively or discharge	Assessment of delirium will be performed utilizing the CAM-ICU

Secondary

Measure	Time frame	Description
The total cost for each patient	Up to 7 days or discharge	Summation of direct-variable, direct-fixed, and overhead costs

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026