BRS and Outcomes in Cardiothoracic Surgery



Status:Recruiting
Conditions:Atrial Fibrillation, Cognitive Studies, Post-Surgical Pain
Therapuetic Areas:Cardiology / Vascular Diseases, Musculoskeletal, Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:11/14/2018
Start Date:September 15, 2017
End Date:December 31, 2019
Contact:Heberto Suarez-Roca, Ph.D.
Email:heberto.suarez.roca@duke.edu
Phone:919-681-9940

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Role of Preoperative Baroreflex Sensitivity on Major Outcomes After Cardiothoracic Surgery

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).

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.

Inclusion Criteria:

- >= 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

Exclusion Criteria:

- 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
We found this trial at
1
site
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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