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Status unknownNCT02699801DIRECTUpdated Nov 3, 2016

Dexmedetomidine Use in ICU Sedation and Postoperative Recovery in Elderly Patients and Post-cardiac Surgery

An interventional study of propofol and Dexmedetomidine in Delirium, Cognitive Decline and Post-operative Quality of Recovery, sponsored by University of British Columbia. Status unknown at 1 site in Canada. Open to participants aged 75 Years to 105 Years. Per ClinicalTrials.gov, last updated 2016-11-03.

Sponsored by University of British Columbia · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Nov 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
75 Years to 105 Years
Sex
All
01

Study 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?
Read the detailed description

Due to advances in surgical and anaesthetic techniques, increasing numbers of elderly patients are undergoing cardiac surgery. Elderly patients with multiple comorbidities undergoing cardiac surgery 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.

Traditionally, outcomes following cardiac surgery were measured in terms of complication rates or mortality rates1. More recently however, quality of life (QoL) measures are increasingly being recognized as important outcome measurements following cardiac surgery2. Factors related to cardiac surgery and perioperative care which could potentially influence later QoL include quality of recovery following surgery, postoperative delirium, and postoperative neurocognitive decline.

Quality of recovery (QoR) is a newer concept, which aims to measure a patient's health status after surgery and anaesthesia. The use of dexmedetomidine during spinal surgery has been associated with improved quality of recovery in the early postoperative period3. There are suggestions that dexmedetomidine attenuates the increase in inflammatory mediators during a stress response4 which could have a role in the post-surgical stress response. There are no studies that have attempted to correlate dexmedetomidine use with quality of recovery following cardiac surgery.

The prevalence of delirium following cardiac surgery in patients over 60 years has been reported in the range 30-52% (5, 6). Delirium is a condition characterized by consciousness disturbances, concentration disorders, memory disturbances and hallucinations. There have been associations made between the choice of sedative and the prevalence of delirium in ICU patients. In a multicenter randomized trial predominantly involving medical patients in the ICU, those assigned to receive dexmedetomidine had a reduced risk of delirium and spent less time undergoing mechanical ventilation7. It is not known if the choice of sedation agent in this population impacts on the incidence of delirium following cardiac surgery. Delirium is associated with increased morbidity, prolonged hospital stay, increased mortality8

Cognitive decline refers to a condition in which intellectual abilities and memory seem impaired when the patient appears to have otherwise recovered from the surgery. It is a condition distinct from delirium or encephalopathy. Cognitive decline is common, and can be persist for months and years, following cardiac surgery. The reported incidence of cognitive decline after coronary artery bypass graft (CABG) has been reported as 53% at hospital discharge, 36% at 6 weeks and 42% at 5 years9. Elderly patient undergoing cardiac surgery are at increased risk for postoperative cognitive decline10. A strong relationship has been reported between cognitive decline and reduced quality of life following cardiac surgery11.

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. We 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. We were also interested as to whether there was an associated improvement in neurocognitive outcomes in this population.

02

Conditions studied

  • Delirium
  • Cognitive Decline
  • Post-operative Quality of Recovery
03

In context

Cognitive Dysfunction

3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.

This study's planned enrollment of 70 is close to the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
75 Years to 105 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Consent refusal
  • Language barrier
  • Allergy to study drugs
  • Receiving other alpha 2 agonists
  • Dementia [mild cognitive impairment can be included]
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Active comparator
    Propofol

    Patients received propofol for post-operative sedation

    Drug: propofol

  • Active comparator
    Dexmedetomidine

    Patients received dexmedetomidine for post-operative sedation

    Drug: Dexmedetomidine

Interventions

  • Drugpropofol

    propofol for post-sternal closure sedation

  • DrugDexmedetomidine

    dexmedetomidine for post-sternal closure sedation

06

What researchers measure

Primary outcomes

  1. Quality of Recovery - 40

    Questionnaire

    Time frame: Post Operative Day 3

Secondary outcomes

  1. Minnesota Cognitive Acuity Screen

    Questionnaire

    Time frame: Post Operative Day 5 and 6 months post operatively

  2. Quality of Life Score SF-36

    Questionnaire

    Time frame: 6 months post operatively

Other outcomes

  1. Other Secondary Outcomes - Number of Incidences of delirium

    Number of Incidences of delirium

    Time frame: Up to 6 months post surgery date

  2. Other Secondary Outcomes - Number of delirious days

    Number of delirious days

    Time frame: Up to 6 months post surgery date

  3. Other Secondary Outcomes - Time to extubation

    Time to extubation

    Time frame: Up to 6 months post surgery date

  4. Other secondary outcomes - Time to being discharge-ready from ICU

    Time to being discharge-ready from ICU

    Time frame: Up to 6 months post surgery date

  5. Other secondary outcome - Length of hospital stay

    Length of hospital stay

    Time frame: Up to 6 months post surgery date

  6. other secondary outcomes - Hospital mortality rate

    Hospital mortality rate

    Time frame: Up to 6 months post surgery date

  7. other secondary outcomes - Adverse events (hypotension, bradycardia, increased troponin, PONV)

    Adverse events (hypotension, bradycardia, increased troponin, PONV)

    Time frame: Up to 6 months post surgery date

07

Study locations

1 of 1 sites recruiting
  • Vancouver General Hospital
    Vancouver, British Columbia, Canada
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 3, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02699801
Lead sponsor
University of British Columbia
Responsible party
Sponsor
First posted
Mar 4, 2016
Start date
Jan 2016
Primary completion
Oct 2017 (estimated)
Completion
Feb 2018 (estimated)
Last update
Nov 3, 2016

Study contacts

Rebecca Grey
Contact
rebecca.grey@vch.ca
Janette Brohan
Contact
janette.brohan@vch.ca
Janette Brohan
principal investigator · UBC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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