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临床试验/NCT02699801
NCT02699801Unknown不适用

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

University of British Columbia1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2016年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
70
试验地点
1
主要终点
Quality of Recovery - 40

研究概览

简要总结

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?

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
75 Years 至 105 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

Propofol

Active Comparator

Patients received propofol for post-operative sedation

干预措施: propofol (Drug)

Dexmedetomidine

Active Comparator

Patients received dexmedetomidine for post-operative sedation

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

Quality of Recovery - 40

时间窗: Post Operative Day 3

Questionnaire

次要结局

  • Quality of Life Score SF-36(6 months post operatively)
  • Minnesota Cognitive Acuity Screen(Post Operative Day 5 and 6 months post operatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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