Surgery
Conditions
Keywords
perioperative, beta-blockers, inflammation, outcomes
Brief summary
Studies have shown that beta-blockers such as atenolol when given in the perioperative period reduce morbidity and mortality. One study showed that atenolol given just during the surgery period, seemed to improve outcomes up to 2 years later. This is hard to explain since beta-blockers act on the body by blocking the effects of adrenalin and thereby lowering heart rate and blood pressure. This study is designed to find out if perioperative atenolol might exert its long term effects through an anti-inflammatory mechanism rather than by lowering heart rate and blood pressure. It is known that inflammation increases after surgery as part of the healing process. However, it is also becoming clear that low-grade chronic inflammation can also lead to long term adverse effects.
Interventions
DRUGatenolol
DRUGplacebo
Sponsors
Medtronic - MITG
Saini Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* elective abdominal, orthopedic, or gynecologic surgery * ability to give informed consent * ability to tolerate beta-blocker therapy * ability to comply with follow-up requirements
Exclusion criteria
* currently receiving beta-blocker therapy * EKG documented 2nd or 3rd degree heart block * EKG documented sinus bradycardia * Serum creatinine \> 2.0 * current treatment asthma * history of rheumatoid arthritis * history of Crohn's disease * history of lupus * history of inflammatory cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative levels of IL-6 and C-Reactive protein | 6 hrs, 48 hrs, 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| IL-10, TNF-α | 6 hrs, 48 hrs, 6 weeks |
Countries
United States
Outcome results
None listed