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

Delirium Clinical Trial

— DIRECT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02699801
• Other study ID #: H15-02301
• Status: Recruiting
• Phase: N/A
• First received: January 27, 2016
• Last updated: November 1, 2016
• Start date: January 2016
• Est. completion date: February 2018

Study information

• Verified date: November 2016
• Source: University of British Columbia
• Contact: Rebecca Grey
• Email: rebecca.grey[@]vch.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: February 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 75 Years to 105 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Drug:
• propofol
propofol for post-sternal closure sedation
• Dexmedetomidine
dexmedetomidine for post-sternal closure sedation

Locations

Country	Name	City	State
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Other Secondary Outcomes - Number of Incidences of delirium	Number of Incidences of delirium	Up to 6 months post surgery date	No
Other	Other Secondary Outcomes - Number of delirious days	Number of delirious days	Up to 6 months post surgery date	No
Other	Other Secondary Outcomes - Time to extubation	Time to extubation	Up to 6 months post surgery date	No
Other	Other secondary outcomes - Time to being discharge-ready from ICU	Time to being discharge-ready from ICU	Up to 6 months post surgery date	No
Other	Other secondary outcome - Length of hospital stay	Length of hospital stay	Up to 6 months post surgery date	No
Other	other secondary outcomes - Hospital mortality rate	Hospital mortality rate	Up to 6 months post surgery date	No
Other	other secondary outcomes - Adverse events (hypotension, bradycardia, increased troponin, PONV)	Adverse events (hypotension, bradycardia, increased troponin, PONV)	Up to 6 months post surgery date	No
Primary	Quality of Recovery - 40	Questionnaire	Post Operative Day 3	No
Secondary	Minnesota Cognitive Acuity Screen	Questionnaire	Post Operative Day 5 and 6 months post operatively	No
Secondary	Quality of Life Score SF-36	Questionnaire	6 months post operatively	No