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Completed

NCT Number: NCT03243279

BRS and Outcomes in 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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Baseline baroreflex sensitivity

    Time frame: 30 min

    Non-invasive BRS testing with BIOPAC MP160

Secondary outcomes

  1. Postoperative day (POD) 1 baroreflex sensitivity

    Time frame: 30 min

    Non-invasive BRS testing with BIOPAC MP160

  2. POD 2 baroreflex sensitivity

    Time frame: 30 min

    Non-invasive BRS testing with BIOPAC MP160

  3. 6 month baroreflex sensitivity

    Time frame: 6 months

    Non-invasive BRS testing with BIOPAC MP160

  4. Acute postoperative pain as assessed by the numeric rating scale (NRS) - 24h

    Time frame: 24 hours

    Median NRS pain score in the first 24h after surgery

  5. Acute postoperative pain as assessed by the numeric rating scale (NRS) - 48h

    Time frame: 48 hours

    Median NRS pain score in the second 24h after surgery

  6. Acute postoperative pain as assessed by the Gracely Box Scale (GBS) - POD1

    Time frame: 15 min

    GBS survey on POD 1

  7. Acute postoperative pain as assessed by the Gracely Box Scale (GBS) - POD2

    Time frame: 15 min

    GBS survey on POD 2

  8. Acute postoperative pain as assessed by the Gracely Box Scale (GBS) - 6 mo

    Time frame: 6 months

    GBS survey at 6 month follow-up visit

  9. Chronic pain as assessed by the change in Brief Pain Inventory score

    Time frame: Baseline, 6 months

    Change from baseline to 6 months postoperatively

  10. Hyperalgesia

    Time frame: 6 months

    Nociceptive threshold as assessed by Von Frey filament testing at 6 month follow-up

  11. Area of hyperalgesia or allodynia

    Time frame: 6 months

    Area surrounding operative incision as assessed by Von Frey filament testing at 6 month follow-up

  12. Postoperative atrial fibrillation

    Time frame: 6 weeks

    Chart review assessment of the occurrence of postoperative atrial fibrillation during hospitalization and up to 6 weeks postoperatively

  13. Postoperative cognitive change

    Time frame: Baseline, 6 months

    Change from baseline to 6 months in the Mini Mental Status Exam score

  14. Baseline psychological distress

    Time frame: 15 min

    As assessed by the Brief Symptom Inventory-18

  15. 6 month psychological distress

    Time frame: 6 months

    As assessed by the Brief Symptom Inventory-18

  16. Baseline frailty

    Time frame: 10 min

    As assessed by the Modified Frailty Index

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Role of Preoperative Baroreflex Sensitivity on Major Outcomes After Cardiothoracic Surgery

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Aug 8, 2017
Registry last updated
Jul 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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