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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01330654

Enrollment

Registered

2011-04-07

Start date

2011-03-31

Completion date

2012-03-31

Last updated

2012-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Event Risk

Keywords

Intermediate risk of adverse cardiac event, Undergoing laparoscopic surgical procedure, Age forty to seventy five

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.

Interventions

DRUGmetoprolol

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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Heart Rate Variability	2 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026