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Clinical Trials/NCT01330654
NCT01330654WithdrawnNot 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 countryStarted: March 2011Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Locations
1
Primary Endpoint
Heart Rate Variability

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Masking
Single (Investigator)

Eligibility Criteria

Ages
40 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • undergoing an elective laparoscopic abdominal surgery less than three hours:
  • cholecystectomy
  • ventral hernia repair
  • umbilical hernia repair
  • gastric bypass or gastric banding

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

Active Comparator

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

Intervention: metoprolol (Drug)

Outcomes

Primary Outcomes

Heart Rate Variability

Time Frame: 2 weeks

Secondary Outcomes

No secondary outcomes reported

Investigators

Study Sites (1)

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