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

NCT02699801 | Unknown

• 1 other identifier: H15-02301
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Quality of Recovery - 40

  Questionnaire

  Post Operative Day 3

Secondary Outcomes (2)

• Minnesota Cognitive Acuity Screen

  Post Operative Day 5 and 6 months post operatively

• Quality of Life Score SF-36

  6 months post operatively

Other Outcomes (7)

• Other Secondary Outcomes - Number of Incidences of delirium

  Up to 6 months post surgery date

• Other Secondary Outcomes - Number of delirious days

  Up to 6 months post surgery date

• Other Secondary Outcomes - Time to extubation

  Up to 6 months post surgery date

Study Arms (2)

Propofol

ACTIVE COMPARATOR

Patients received propofol for post-operative sedation

Drug: propofol

Dexmedetomidine

ACTIVE COMPARATOR

Patients received dexmedetomidine for post-operative sedation

Drug: Dexmedetomidine

Interventions

propofol DRUG

propofol for post-sternal closure sedation

Propofol

Dexmedetomidine DRUG

dexmedetomidine for post-sternal closure sedation

Dexmedetomidine

Eligibility Criteria

• Age: 75 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, Canada

RECRUITING

MeSH Terms

Conditions

Delirium; Cognitive Dysfunction

Interventions

Propofol; Dexmedetomidine

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Janette Brohan

  UBC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Grey

CONTACT

rebecca.grey@vch.ca

Janette Brohan

CONTACT

janette.brohan@vch.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2016
• First Posted: March 4, 2016
• Study Start: January 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: February 1, 2018
• Last Updated: November 3, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)