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

June 25, 2012 updated by: University of California, San Francisco

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fresno, California, United States, 93701
        • Community Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Beta blocker
These patients will be randomized to receive a standard dose of metoprolol (50mg) starting two weeks prior to surgery
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.
NO_INTERVENTION: Control
This arm will receive no additional treatment prior to surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Heart Rate Variability
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Study Director: Ralph Wessel, MD, UCSF Fresno Department of Internal Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (ACTUAL)

March 1, 2012

Study Completion (ACTUAL)

March 1, 2012

Study Registration Dates

First Submitted

April 5, 2011

First Submitted That Met QC Criteria

April 6, 2011

First Posted (ESTIMATE)

April 7, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

June 27, 2012

Last Update Submitted That Met QC Criteria

June 25, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010030

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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