Duke University Medical Center
Durham, North Carolina, 27710, United States
NCT Number: NCT03243279
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).
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Notify Me18 year and older
All sexes
Observational
Durham, North Carolina, 27710, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 30 min
Non-invasive BRS testing with BIOPAC MP160
Time frame: 30 min
Non-invasive BRS testing with BIOPAC MP160
Time frame: 30 min
Non-invasive BRS testing with BIOPAC MP160
Time frame: 6 months
Non-invasive BRS testing with BIOPAC MP160
Time frame: 24 hours
Median NRS pain score in the first 24h after surgery
Time frame: 48 hours
Median NRS pain score in the second 24h after surgery
Time frame: 15 min
GBS survey on POD 1
Time frame: 15 min
GBS survey on POD 2
Time frame: 6 months
GBS survey at 6 month follow-up visit
Time frame: Baseline, 6 months
Change from baseline to 6 months postoperatively
Time frame: 6 months
Nociceptive threshold as assessed by Von Frey filament testing at 6 month follow-up
Time frame: 6 months
Area surrounding operative incision as assessed by Von Frey filament testing at 6 month follow-up
Time frame: 6 weeks
Chart review assessment of the occurrence of postoperative atrial fibrillation during hospitalization and up to 6 weeks postoperatively
Time frame: Baseline, 6 months
Change from baseline to 6 months in the Mini Mental Status Exam score
Time frame: 15 min
As assessed by the Brief Symptom Inventory-18
Time frame: 6 months
As assessed by the Brief Symptom Inventory-18
Time frame: 10 min
As assessed by the Modified Frailty Index
Duke University
Other
Role of Preoperative Baroreflex Sensitivity on Major Outcomes After Cardiothoracic Surgery
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