Atrial Fibrillation, Coronary Artery Disease
Conditions
Brief summary
The purpose of this study is assess the incidence of postoperative atrial fibrillation (POAF) within one week of surgery in patients who receive pre-surgical stellate ganglion blockade with liposomal bupivacaine, compared to those receiving a saline placebo, using continuous electrocardiographic monitoring via wearable ECG devices.
Interventions
DRUGLiposomal bupivacaine
Patients undergoing isolated coronary artery bypass grafting will receive a stellate ganglion block using liposomal bupivacaine prior to surgery
DRUGPlacebo
Patients undergoing isolated coronary artery bypass grafting will receive a saline placebo injection to the stellate ganglion prior to surgery
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged ≥40 years scheduled to undergo isolated coronary artery bypass grafting will be eligible. * Cases will also remain eligible if, after the initial surgical listing, additional procedures-such as valvular interventions or septal myectomy-are performed, OR if coronary artery bypass grafting (CABG) is listed as the primary intervention with other procedures noted as possible additional interventions. * Cases will also remain eligible if additional procedures-such as left atrial appendage ligation, MAZE procedure, cryotherapy, or pulmonary vein isolation-are concomitantly listed with the CABG.
Exclusion criteria
* Permanent atrial fibrillation * Mechanical circulatory support implant or explant * Procedures not requiring cardiopulmonary bypass * Heart and/or lung transplant patients * Active infection/sepsis * Pre-operative anti-arrhythmic use (aside from beta-blockers). * Participant has a known allergy to adhesives or hydrogels. * Participant has a visible skin injury or broken skin at the location for study device placement. * Participant does not have the competency to wear the device for the prescribed patching period. * Participant has a neuro-stimulator, as it may disrupt the quality of ECG data. * Participants who are pregnant. In accordance with Mayo Clinic's standard cardiac surgery protocol, all women of childbearing potential undergo routine preoperative pregnancy testing. Pregnancy status will therefore be confirmed prior to enrollment. Any participant with a positive pregnancy test will be deemed ineligible and will not be enrolled in the study. * Participants who lack the capacity to provide informed consent will not be approached or enrolled in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of new-onset postoperative atrial fibrillation (POAF) within one week of isolated coronary artery bypass grafting (CABG) surgery | 1 week | Total number of patients to experience postoperative atrial fibrillation within one week of CABG surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total duration of postoperative atrial fibrillation (POAF) episodes within the first postoperative week | 1 week | Duration of postoperative atrial fibrillation episodes will assessed via continuous ECG monitoring and reported in minutes |
| Number of patients with successful stellate ganglion blockade | 1 week | Success rate of the stellate ganglion blockade is defined as a ≥1.0°C increase in ipsilateral hand skin temperature from baseline and/or a reduction in skin sympathetic nerve activity (SKNA) as measured by noninvasive surface recordings pre- and post-block. |
Countries
United States
Contacts
CONTACTAnesthesia Clinical Research Unit (ACRU) Study Team
PRINCIPAL_INVESTIGATORJuan G. Ripoll Sanz, MD
Mayo Clinic
Outcome results
None listed