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Status unknownNCT00202358Updated Jun 17, 2008

Perioperative Effect of Atenolol on Cytokine Profiles

A Phase 4 interventional study of atenolol and placebo in Surgery, sponsored by Saini Foundation. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-06-17.

Sponsored by Saini Foundation · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2008), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Surgery

Keywords

  • perioperative
  • beta-blockers
  • inflammation
  • outcomes
03

In context

Lead sponsor

This is the only study on the registry with Saini Foundation as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Placebo comparator
    placebo

    Drug: placebo

  • Experimental
    atenolol

    Drug: atenolol

Interventions

  • Drugatenolol
  • Drugplacebo
06

What researchers measure

Primary outcomes

  1. Postoperative levels of IL-6 and C-Reactive protein

    Time frame: 6 hrs, 48 hrs, 6 weeks

Secondary outcomes

  1. IL-10, TNF-α

    Time frame: 6 hrs, 48 hrs, 6 weeks

07

Study locations

1 site
  • Cape Cod Hospital
    Hyannis, Massachusetts 02601, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00202358
Lead sponsor
Saini Foundation
Collaborators
Medtronic - MITG
First posted
Sep 20, 2005
Start date
Nov 2002
Primary completion
Nov 2007
Completion
Sep 2008 (estimated)
Last update
Jun 17, 2008

Study contacts

Vikas Saini, M.D.
principal investigator · Dept Medicine, Cape Cod Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.

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