Heart Rate Variability (HRV) to Evaluate Surgical Risk on Patients on Beta Blockers

This study has been withdrawn prior to enrollment.
(no patients were enrolled. Study was closed prior to study start.)
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01330654
First received: April 5, 2011
Last updated: June 25, 2012
Last verified: June 2012

April 5, 2011
June 25, 2012
March 2011
March 2012   (final data collection date for primary outcome measure)
Heart Rate Variability [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01330654 on ClinicalTrials.gov Archive Site
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Heart Rate Variability (HRV) to Evaluate Surgical Risk on Patients on Beta Blockers
Using Heart Rate Variability to Analyze the Effect of Beta Blockers on Intermediate Risk Patients Undergoing Laparoscopic Surgical Procedures

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.

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Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Cardiac Event Risk
Drug: metoprolol
50mg PO BID starting two weeks prior to surgery. Patients will be reevaluated one week prior to surgery. If their pulse is above 70, the dose will be increased to 100mg BID. If the HR is 50-70, the dose will not be changed. If the pulse is below 50, the dose will be decreased to 25mg. This dose will be continued for thirty days after operation.
  • Active Comparator: Beta blocker
    These patients will be randomized to receive a standard dose of metoprolol (50mg) starting two weeks prior to surgery
    Intervention: Drug: metoprolol
  • No Intervention: Control
    This arm will receive no additional treatment prior to surgery

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
March 2012
March 2012   (final data collection date for primary outcome measure)

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
      • obesity
      • 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
    • asthma
    • COPD
    • hypersensitivity to beta blockers
    • heart rate < 60
  • currently taking a calcium channel blocker
  • urgent or emergent surgery
Both
40 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01330654
2010030
Yes
Jim Davis, Interim Program Director, Department of Surgery, UCSF Fresno
University of California, San Francisco
Not Provided
Study Director: Ralph Wessel, MD UCSF Fresno Department of Internal Medicine
University of California, San Francisco
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP