Dexmedetomidine Use in ICU Sedation and Postoperative Recovery in Elderly Patients and Post-cardiac Surgery (DIRECT)
Primary Purpose
Delirium, Cognitive Decline, Post-operative Quality of Recovery
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
propofol
Dexmedetomidine
Sponsored by
About this trial
This is an interventional prevention trial for Delirium
Eligibility Criteria
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]
Sites / Locations
- Vancouver General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Propofol
Dexmedetomidine
Arm Description
Patients received propofol for post-operative sedation
Patients received dexmedetomidine for post-operative sedation
Outcomes
Primary Outcome Measures
Quality of Recovery - 40
Questionnaire
Secondary Outcome Measures
Minnesota Cognitive Acuity Screen
Questionnaire
Quality of Life Score SF-36
Questionnaire
Full Information
NCT ID
NCT02699801
First Posted
January 27, 2016
Last Updated
November 1, 2016
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT02699801
Brief Title
Dexmedetomidine Use in ICU Sedation and Postoperative Recovery in Elderly Patients and Post-cardiac Surgery
Acronym
DIRECT
Official Title
Dexmedetomidine Use in ICU Sedation and Postoperative Recovery in Elderly Patients and Post-cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
February 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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?
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Cognitive Decline, Post-operative Quality of Recovery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Propofol
Arm Type
Active Comparator
Arm Description
Patients received propofol for post-operative sedation
Arm Title
Dexmedetomidine
Arm Type
Active Comparator
Arm Description
Patients received dexmedetomidine for post-operative sedation
Intervention Type
Drug
Intervention Name(s)
propofol
Intervention Description
propofol for post-sternal closure sedation
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
dexmedetomidine for post-sternal closure sedation
Primary Outcome Measure Information:
Title
Quality of Recovery - 40
Description
Questionnaire
Time Frame
Post Operative Day 3
Secondary Outcome Measure Information:
Title
Minnesota Cognitive Acuity Screen
Description
Questionnaire
Time Frame
Post Operative Day 5 and 6 months post operatively
Title
Quality of Life Score SF-36
Description
Questionnaire
Time Frame
6 months post operatively
Other Pre-specified Outcome Measures:
Title
Other Secondary Outcomes - Number of Incidences of delirium
Description
Number of Incidences of delirium
Time Frame
Up to 6 months post surgery date
Title
Other Secondary Outcomes - Number of delirious days
Description
Number of delirious days
Time Frame
Up to 6 months post surgery date
Title
Other Secondary Outcomes - Time to extubation
Description
Time to extubation
Time Frame
Up to 6 months post surgery date
Title
Other secondary outcomes - Time to being discharge-ready from ICU
Description
Time to being discharge-ready from ICU
Time Frame
Up to 6 months post surgery date
Title
Other secondary outcome - Length of hospital stay
Description
Length of hospital stay
Time Frame
Up to 6 months post surgery date
Title
other secondary outcomes - Hospital mortality rate
Description
Hospital mortality rate
Time Frame
Up to 6 months post surgery date
Title
other secondary outcomes - Adverse events (hypotension, bradycardia, increased troponin, PONV)
Description
Adverse events (hypotension, bradycardia, increased troponin, PONV)
Time Frame
Up to 6 months post surgery date
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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]
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca Grey
Email
rebecca.grey@vch.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Janette Brohan
Email
janette.brohan@vch.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janette Brohan
Organizational Affiliation
UBC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Grey
Email
rebecca.grey@vch.ca
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dexmedetomidine Use in ICU Sedation and Postoperative Recovery in Elderly Patients and Post-cardiac Surgery
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