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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Intraoperative Heart Rate Thresholds and Postoperative Mortality

NCT07075744

HEART RATE

COMPLETED

Cerebral Autoregulation Monitoring During Cardiac Surgery

NCT00981474

Thoracic Surgery Cardiopulmonary Bypass

COMPLETED NA

Intraoperative Fetal Heart Rate (FHR) Monitoring: a Feasibility Study

NCT02950896

Fetal Monitoring Labor, Obstetric

TERMINATED

Effect of Preoperative Beta Blocker Use Postoperative Renal Function in the Patients Undergoing Liver Transplantation

NCT03633812

End Stage Liver Disease Acute Kidney Injury

UNKNOWN

Systolic Pressure Index in Assessing the Risk of Cardiovascular Events

NCT00925964

Cardio-vascular Events

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Event Risk

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Beta blocker

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

Group Type ACTIVE_COMPARATOR

metoprolol

Intervention Type DRUG

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.

Control

This arm will receive no additional treatment prior to surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No