NCT03243279

BRS and Outcomes in Cardiothoracic Surgery

Role of Preoperative Baroreflex Sensitivity on Major Outcomes After Cardiothoracic Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 72 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Pain, Postoperative
• Atrial Fibrillation
• Cognitive Dysfunction

Timeline

• Start date: 2017-09-15
• Primary completion: 2021-12-15
• Completion: 2022-05-31
• First posted: 2017-08-08
• Last updated: 2022-07-21

Locations

1 site across 1 country: United States