Recruiting

Dexmedetomidine

Sponsor:

University of British Columbia

Code:

NCT02699801

Conditions

Delirium

Cognitive Decline

Post-operative Quality of Recovery

Eligibility Criteria

Sex: All

Age: 75+

Healthy Volunteers: Not accepted

Interventions

propofol

Dexmedetomidine

Study Details

Brief summary:

Increasing numbers of elderly patients are undergoing cardiac surgery. Elderly patients may have prolonged recovery following cardiac surgery when compared to other groups of patients, and are at higher risk of postoperative delirium, postoperative neurocognitive decline and reduced quality of life following hospital discharge.

The goals of sedation and analgesia for patients following cardiac surgery are multifold and include postoperative pain relief, the facilitation of ventilation, resolution of hypothermia and normalization of electrolyte balances. The choice of sedative agent however can impact postoperative outcomes. Dexmedetomidine has been associated with improved quality of recovery in patients undergoing major spine surgery and with a reduced incidence of delirium, both of which can impact a patient's quality of life following surgery. The investigators hypothesized that the use of dexmedetomidine as a sedative agent immediately following cardiac surgery in elderly patients would result in improved quality of recovery and a reduced incidence of delirium in the postoperative period, when compared to propofol. The investigators were also interested as to whether there was an associated improvement in neurocognitive outcomes in this population.

Questions:

  • Does the use of dexmedetomidine as a sedative agent in ICU in elderly patients following cardiac surgery result in improved Quality of Recovery scores when compared with propofol?
  • Does the use of dexmedetomidine as a sedative agent in ICU in elderly patients following CABG+/- AVR result in a reduced incidence of postoperative delirium as compared to propofol?
  • Do these patients subsequently have a reduction in cognitive decline?

Conditions

Delirium

Cognitive Decline

Post-operative Quality of Recovery

Study ID

NCT02699801

Start date

Jan, 2016

Status verified date

Nov, 2016

Completion date

Feb, 2018

Anticipated

Primary completion date

Oct, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 75+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • adults over 75yrs undergoing on-pump CABG +/- AVR

Exclusion Criteria:

  • Consent refusal
  • Language barrier
  • Allergy to study drugs
  • Receiving other alpha 2 agonists
  • Dementia \[mild cognitive impairment can be included\]

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Propofol

Patients received propofol for post-operative sedation

active comparator: Dexmedetomidine

Patients received dexmedetomidine for post-operative sedation

Interventions

propofol

propofol for post-sternal closure sedation

Dexmedetomidine

dexmedetomidine for post-sternal closure sedation

Primary outcome measure

  • Quality of Recovery - 40 [ Time Frame: Post Operative Day 3 ]

Central Contacts and Locations

Central contacts

Locations

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada

Contacts

More Information

Sponsor

University of British Columbia

Last update posted

Nov 3, 2016

Last verified

Nov, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2016-11-03.