Using Heart Rate Variability to Analyze the Effect of Beta Blockers on Intermediate Risk Patients Undergoing Laparoscopic Surgical Procedures
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- Heart Rate Variability
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
- •hypersensitivity to beta blockers
- •heart rate < 60
- •currently taking a calcium channel blocker
- •urgent or emergent surgery
Arms & Interventions
Beta blocker
These patients will be randomized to receive a standard dose of metoprolol (50mg) starting two weeks prior to surgery
Intervention: metoprolol (Drug)
Outcomes
Primary Outcomes
Heart Rate Variability
Time Frame: 2 weeks
Secondary Outcomes
No secondary outcomes reported