Clinical trial NCT01330654: Heart Rate Variability (HRV) to Evaluate Surgical Risk on Patients on Beta Blockers
Official title: Using Heart Rate Variability to Analyze the Effect of Beta Blockers on Intermediate Risk Patients Undergoing Laparoscopic Surgical Procedures
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cardiac Event Risk
Keywords: Intermediate risk of adverse cardiac event
Undergoing laparoscopic surgical procedure
Age forty to seventy five
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2011-04-07
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


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

Primary outcomes:
measure: Heart Rate Variability
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Community Regional Medical Center
state: California
Study officials:
affiliation: UCSF Fresno Department of Internal Medicine
name: Ralph Wessel, MD
role: STUDY_DIRECTOR
References:
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