This trial is active, not recruiting.

Condition surgery
Treatments atenolol, placebo
Phase phase 4
Sponsor Saini Foundation
Collaborator Covidien
Start date November 2002
End date November 2007
Trial size 60 participants
Trial identifier NCT00202358, PEACK


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Placebo Comparator)

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
time frame: 6 hrs, 48 hrs, 6 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title The Effect of Perioperative Atenolol on Post-Operative Cytokines
Principal investigator Vikas Saini, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in June 2008.
Information provided to ClinicalTrials.gov by Saini Foundation.