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

Not Applicable

Withdrawn

• Conditions: Cardiac Event Risk
• Interventions: Drug: metoprolol

• Registration Number: NCT01330654
• Lead Sponsor: University of California, San Francisco

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 Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-04-05
• Study First Submitted QC: 2011-04-06
• Study First Posted: 2011-04-07
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-25
• Last Update Posted: 2012-06-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Heart Rate Variability	2 weeks

Trial Locations

Locations (1)

Community Regional Medical Center; 🇺🇸 Fresno, California, United States