Role of Preoperative Baroreflex Sensitivity on Major Outcomes After Cardiothoracic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Baseline baroreflex sensitivity
研究概览
简要总结
The purpose of this study is to determine whether baroreceptor sensitivity (the ability of your body to change your heart rate and/or blood pressure in response to a situation) has any effect on how likely you are to suffer certain events after heart or lung surgery. The postoperative events that the investigators will be studying are pain after surgery, atrial fibrillation (an irregular heart rhythm), and cognitive dysfunction (a decline in mental abilities).
详细描述
The purpose of this study is to determine if preoperative baroreceptor sensitivity (BRS) correlates with major outcomes after cardiac and thoracic surgery, including acute and chronic pain, atrial arrhythmias, and cognitive function. To test this hypothesis, approximately 95 patients will be enrolled, and spontaneous baroreceptor sensitivity will be measured prior to surgery as well as immediately postoperatively. Outcomes will include acute pain using the numeric rating scale, Brief Pain Inventory, and Gracely Box Scale administered preoperatively, on postoperative days 1 and 2 and by phone at 6-weeks postoperatively. Chronic pain will be assessed at 6-month follow-up visit via hyperalgesia testing using Von Frey filaments. Postoperative atrial arrhythmias will be assessed by review of postoperative telemetry, the electronic medical record, and ECG performed prior to discharge. Finally, cognitive function will be assess via Mini-Mental State examination administered preoperative and at the 6-month follow-up visit. Association between BRS and the outcomes of interest will be tested with regression models adjusted for appropriate covariates. Significance threshold alpha will be adjusted for the number of statistical tests using the Bonferroni correction. Our hypothesis is that patients with impaired preoperative BRS will have an increased incidence of acute and chronic postoperative pain, atrial fibrillation, and cognitive decline after surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>= 18 years of age
- •Undergoing cardiac (coronary artery bypass grafting [CABG], CABG + valve, or valve only) or thoracic (video-assisted thoracoscopic [VATS] approach to lobectomy) surgery
排除标准
- •Any preexisting pain condition (defined as pain of >=3 months duration prior to enrollment)
- •Pain at the time of enrollment interview
- •Need for preoperative analgesics
- •Preexisting chronic or paroxysmal atrial fibrillation
- •Preexisting atrial or ventricular arrhythmia
- •Need for preoperative anti-arrhythmic medication
- •History of symptomatic cerebrovascular disease (e.g., prior stroke) with residual deficits
- •Alcoholism (>2 drinks/day)
- •Psychiatric illness (any clinical diagnosis requiring therapy)
- •Drug abuse (any illicit drug use in the preceding 3 months before surgery)
- •Hepatic insufficiency (liver function tests > 1.5 times the upper limit of normal)
- •Severe pulmonary insufficiency (home oxygen)
- •Renal failure (serum creatinine >2.0 mg/dL)
- •Non-English speaking
- •Unable to read
- •Participants who score <24 on baseline Mini Mental State examination
结局指标
主要结局
Baseline baroreflex sensitivity
时间窗: 30 min
Non-invasive BRS testing with BIOPAC MP160
次要结局
- POD 2 baroreflex sensitivity(30 min)
- Chronic pain as assessed by the change in Brief Pain Inventory score(Baseline, 6 months)
- Hyperalgesia(6 months)
- Baseline psychological distress(15 min)
- Acute postoperative pain as assessed by the numeric rating scale (NRS) - 48h(48 hours)
- Acute postoperative pain as assessed by the Gracely Box Scale (GBS) - POD1(15 min)
- Postoperative cognitive change(Baseline, 6 months)
- 6 month psychological distress(6 months)
- Postoperative day (POD) 1 baroreflex sensitivity(30 min)
- 6 month baroreflex sensitivity(6 months)
- Acute postoperative pain as assessed by the numeric rating scale (NRS) - 24h(24 hours)
- Acute postoperative pain as assessed by the Gracely Box Scale (GBS) - POD2(15 min)
- Acute postoperative pain as assessed by the Gracely Box Scale (GBS) - 6 mo(6 months)
- Area of hyperalgesia or allodynia(6 months)
- Postoperative atrial fibrillation(6 weeks)
- Baseline frailty(10 min)