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

Overview[ - collapse ][ - ]

Purpose 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.
ConditionCardiac Event Risk
InterventionDrug: metoprolol
PhaseN/A
SponsorUniversity of California, San Francisco
Responsible PartyUniversity of California, San Francisco
ClinicalTrials.gov IdentifierNCT01330654
First ReceivedApril 5, 2011
Last UpdatedJune 25, 2012
Last verifiedJune 2012

Tracking Information[ + expand ][ + ]

First Received DateApril 5, 2011
Last Updated DateJune 25, 2012
Start DateMarch 2011
Estimated Primary Completion DateMarch 2012
Current Primary Outcome MeasuresHeart Rate Variability [Time Frame: 2 weeks] [Designated as safety issue: No]
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleHeart Rate Variability (HRV) to Evaluate Surgical Risk on Patients on Beta Blockers
Official TitleUsing Heart Rate Variability to Analyze the Effect of Beta Blockers on Intermediate Risk Patients Undergoing Laparoscopic Surgical Procedures
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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhaseN/A
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)
ConditionCardiac Event Risk
InterventionDrug: 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.
Study Arm (s)
  • Active Comparator: Beta blocker
    These patients will be randomized to receive a standard dose of metoprolol (50mg) starting two weeks prior to surgery
  • No Intervention: Control
    This arm will receive no additional treatment prior to surgery

Recruitment Information[ + expand ][ + ]

Recruitment StatusWithdrawn
Estimated EnrollmentNot Provided
Estimated Completion DateMarch 2012
Estimated Primary Completion DateMarch 2012
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

- 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
GenderBoth
Ages40 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT01330654
Other Study ID Numbers2010030
Has Data Monitoring CommitteeYes
Information Provided ByUniversity of California, San Francisco
Study SponsorUniversity of California, San Francisco
CollaboratorsNot Provided
Investigators Study Director: Ralph Wessel, MD UCSF Fresno Department of Internal Medicine
Verification DateJune 2012

Locations[ + expand ][ + ]

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