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Clinical Trials/NCT01330654
NCT01330654
Withdrawn
Not Applicable

Using Heart Rate Variability to Analyze the Effect of Beta Blockers on Intermediate Risk Patients Undergoing Laparoscopic Surgical Procedures

University of California, San Francisco1 site in 1 countryMarch 2011
Interventionsmetoprolol

Overview

Phase
Not Applicable
Intervention
metoprolol
Conditions
Cardiac Event Risk
Sponsor
University of California, San Francisco
Locations
1
Primary Endpoint
Heart Rate Variability
Status
Withdrawn
Last Updated
13 years ago

Overview

Brief Summary

Beta blockers have been shown to decrease the risk of intraoperative cardiac events in patients at high cardiac risk. However, they have also been associated with side effects (for instance, stroke.) The role of beta blockers in patients at intermediate cardiac risk undergoing surgery is controversial. Heart rate variability is a way of evaluating the cardiac function of a patient. Decreased heart rate variability is associated with early cardiac death in patients with congestive heart failure (CHF) and after a heart attack. It has been shown to transiently decrease in patients in hemorrhagic shock after trauma and returns to normal after resuscitation in trauma and burn patients. The investigators hypothesize that beta blockers will maintain pre operative heart rate variability in patients with intermediate risk of cardiac events during operative intervention with laparoscopic surgery.

Registry
clinicaltrials.gov
Start Date
March 2011
End Date
March 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • age 40-75 years old
  • intermediate risk of adverse cardiac events:
  • renal insufficiency (CrCl \< 60)
  • diabetes mellitus
  • two of the following:
  • age \> 50
  • hypertension
  • hyperlipidemia
  • hypercholesterolemia
  • prior stroke

Exclusion Criteria

  • currently taking a beta blocker
  • prior heart attack
  • rhythm other than sinus on ECG
  • contraindication to beta blockers:
  • decompensated CHF
  • severe valvular disease
  • hypersensitivity to beta blockers
  • heart rate \< 60
  • currently taking a calcium channel blocker
  • urgent or emergent surgery

Arms & Interventions

Beta blocker

These patients will be randomized to receive a standard dose of metoprolol (50mg) starting two weeks prior to surgery

Intervention: metoprolol

Outcomes

Primary Outcomes

Heart Rate Variability

Time Frame: 2 weeks

Study Sites (1)

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