Heart Rate Variability (HRV) to Evaluate Surgical Risk on Patients on Beta Blockers
Overview[ - collapse ][ - ]
Purpose | 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. |
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Condition | Cardiac Event Risk |
Intervention | Drug: metoprolol |
Phase | N/A |
Sponsor | University of California, San Francisco |
Responsible Party | University of California, San Francisco |
ClinicalTrials.gov Identifier | NCT01330654 |
First Received | April 5, 2011 |
Last Updated | June 25, 2012 |
Last verified | June 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | April 5, 2011 |
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Last Updated Date | June 25, 2012 |
Start Date | March 2011 |
Estimated Primary Completion Date | March 2012 |
Current Primary Outcome Measures | Heart Rate Variability [Time Frame: 2 weeks] [Designated as safety issue: No] |
Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | Heart Rate Variability (HRV) to Evaluate Surgical Risk on Patients on Beta Blockers |
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Official Title | Using Heart Rate Variability to Analyze the Effect of Beta Blockers on Intermediate Risk Patients Undergoing Laparoscopic Surgical Procedures |
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 Provided |
Study Type | Interventional |
Study Phase | N/A |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator) |
Condition | Cardiac Event Risk |
Intervention | Drug: 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. |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Withdrawn |
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Estimated Enrollment | Not Provided |
Estimated Completion Date | March 2012 |
Estimated Primary Completion Date | March 2012 |
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 |
Gender | Both |
Ages | 40 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01330654 |
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Other Study ID Numbers | 2010030 |
Has Data Monitoring Committee | Yes |
Information Provided By | University of California, San Francisco |
Study Sponsor | University of California, San Francisco |
Collaborators | Not Provided |
Investigators | Study Director: Ralph Wessel, MD UCSF Fresno Department of Internal Medicine |
Verification Date | June 2012 |
Locations[ + expand ][ + ]
Community Regional Medical Center | Fresno, California, United States, 93701 |
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