Perioperative Effect of Atenolol on Cytokine Profiles

Saini Foundation

Status and phase: Unknown; Phase 4

Conditions: Surgery

Treatments: Drug: placebo; Drug: atenolol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00202358

PEACK

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Treatment:

Drug: placebo

atenolol

Experimental group

Treatment:

Drug: atenolol