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

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01378741
• Other study ID #: UHN10-0771A
• Status: Completed
• Phase: N/A
• First received: June 20, 2011
• Last updated: April 17, 2015
• Start date: April 2011
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: April 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiac Disease
• Delirium
• Heart Diseases

Intervention

Drug:
• Propofol
Upon arrival to ICU patients will receive a propofol 2-6mg/kg infusion until tracheal extubation
• Dexmedetomidine
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.

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Hospira, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dichotomous outcome, a number of patients with delirium in the two study groups.	Assessment of delirium will be performed utilizing the CAM-ICU	up to 7 days postoperatively or discharge	No
Secondary	The total cost for each patient	Summation of direct-variable, direct-fixed, and overhead costs	Up to 7 days or discharge	No