BRS and Outcomes in Cardiothoracic Surgery

Completed

• Conditions: Atrial Fibrillation; Cognitive Dysfunction; Pain, Postoperative

• Registration Number: NCT03243279
• Lead Sponsor: Duke University

Brief 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.

Study Timeline

• Study First Submitted: 2017-08-02
• Study First Submitted QC: 2017-08-03
• Study First Posted: 2017-08-08
• Study Start: 2017-09-15
• Primary Completion: 2021-12-15
• Status Verified: 2022-02
• Study Completion: 2022-05-31
• Last Update Submitted: 2022-07-20
• Last Update Posted: 2022-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Baseline baroreflex sensitivity	30 min	Non-invasive BRS testing with BIOPAC MP160

Secondary Outcome Measures

Name	Time	Method
POD 2 baroreflex sensitivity	30 min	Non-invasive BRS testing with BIOPAC MP160
Chronic pain as assessed by the change in Brief Pain Inventory score	Baseline, 6 months	Change from baseline to 6 months postoperatively
Hyperalgesia	6 months	Nociceptive threshold as assessed by Von Frey filament testing at 6 month follow-up
Baseline psychological distress	15 min	As assessed by the Brief Symptom Inventory-18
Acute postoperative pain as assessed by the Gracely Box Scale (GBS) - POD1	15 min	GBS survey on POD 1
Acute postoperative pain as assessed by the numeric rating scale (NRS) - 48h	48 hours	Median NRS pain score in the second 24h after surgery
Postoperative cognitive change	Baseline, 6 months	Change from baseline to 6 months in the Mini Mental Status Exam score
6 month psychological distress	6 months	As assessed by the Brief Symptom Inventory-18
Postoperative day (POD) 1 baroreflex sensitivity	30 min	Non-invasive BRS testing with BIOPAC MP160
6 month baroreflex sensitivity	6 months	Non-invasive BRS testing with BIOPAC MP160
Acute postoperative pain as assessed by the numeric rating scale (NRS) - 24h	24 hours	Median NRS pain score in the first 24h after surgery
Acute postoperative pain as assessed by the Gracely Box Scale (GBS) - POD2	15 min	GBS survey on POD 2
Acute postoperative pain as assessed by the Gracely Box Scale (GBS) - 6 mo	6 months	GBS survey at 6 month follow-up visit
Area of hyperalgesia or allodynia	6 months	Area surrounding operative incision as assessed by Von Frey filament testing at 6 month follow-up
Postoperative atrial fibrillation	6 weeks	Chart review assessment of the occurrence of postoperative atrial fibrillation during hospitalization and up to 6 weeks postoperatively
Baseline frailty	10 min	As assessed by the Modified Frailty Index

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States