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Perioperative Effect of Atenolol on Cytokine Profiles

Phase 4
Conditions
Surgery
Interventions
Drug: placebo
Registration Number
NCT00202358
Lead Sponsor
Saini Foundation
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
60
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
placeboplacebo-
atenololatenolol-
Primary Outcome Measures
NameTimeMethod
Postoperative levels of IL-6 and C-Reactive protein6 hrs, 48 hrs, 6 weeks
Secondary Outcome Measures
NameTimeMethod
IL-10, TNF-α6 hrs, 48 hrs, 6 weeks

Trial Locations

Locations (1)

Cape Cod Hospital

🇺🇸

Hyannis, Massachusetts, United States

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