The Effect of Perioperative Atenolol on Post-Operative Cytokines
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Saini Foundation
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Postoperative levels of IL-6 and C-Reactive protein
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
placebo
Intervention: placebo (Drug)
atenolol
Intervention: atenolol (Drug)
Outcomes
Primary Outcomes
Postoperative levels of IL-6 and C-Reactive protein
Time Frame: 6 hrs, 48 hrs, 6 weeks
Secondary Outcomes
- IL-10, TNF-α(6 hrs, 48 hrs, 6 weeks)