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Due to difficulty with recruiting patients meeting the inclusion criteria the PI decided to retire this project.
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Angiotensin converting enzyme inhibitors (ACEI's) and Angiotensin receptor blockers (ARB's) are commonly used anti-hypertensive medications that may have implications on the management of a patient undergoing surgery. Limited research has looked at the effects of these medications on perioperative complications and mortality. Some studies conducted on small groups of inpatients with advanced vascular disease undergoing vascular surgery or coronary artery bypass grafting (CABG), suggest exacerbation of hypotension (low blood pressure) in patients who continued taking ACEI's or ARB's on the morning of their procedure. In addition, cases of low blood pressure (BP) that were refractory to standard treatment were reported. One recent retrospective study reported no difference in severe hypotension and only a modest difference in moderate hypotension managed by conventional treatment, but did not adequately address the risk of preoperative hypertension. A study recently published by the investigators (Twersky et al., 2014) in over 600 patients demonstrated no difference in preoperative hypertension in ambulatory surgery and same day admission patients. There has been limited data stratifying the degree of low BP based on severity but these were not done in ambulatory patients, and neither was the degree of high BP from discontinuing these medications addressed. As such, no uniform consensus has been reached and clinicians are unclear as to whether the reported inpatient findings are applicable to the outpatients, since they differ in many respects. The investigators propose to evaluate whether ACEI's and ARB's discontinued preoperatively have a negative impact on perioperative hemodynamics and patient outcome in a group of ambulatory and same day surgical patients. Similar to studies done on inpatients, the investigators will also evaluate patients receiving a standardized general anesthetic for hemodynamics following induction of anesthesia until surgical incision.
The investigators hypothesize that continuing ACEI's and ARB's in the preoperative period does not result in an increased risk of severe hypotension (low blood pressure) following induction of general anesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Discontinue ACEI or ARB | No Intervention | Patients in this group will not take the ACE or ARB 24 hours prior to their procedure. | |
| Continue ACEI or ARB | Active Comparator | Patients in this group will take an ACE or ARB on the day of surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACEI or ARB | Drug | Angiotensin converting enzyme inhibitors (ACEI's) and Angiotensin receptor blockers (ARB's) - commonly used anti-hypertensive medications |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of moderate hypotension | Presence of moderate hypotension (SBP<90 or a change of >30% from pre-induction baseline), in the intraoperative setting and in the post-anesthesia care unit | Through study completion, projected 2-3 years |
| Presence of severe hypotension | Presence of severe hypotension (SBP<65) between induction and incision | Through study completion, projected 2-3 years |
| Measure | Description | Time Frame |
|---|---|---|
| The prevalence of cancellation of surgery secondary to unstable BP | Through study completion, projected 2-3 years | |
| The number and dose of medications to treat BP | Through study completion, projected 2-3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ketan Shevde, MD | State University of New York - Downstate Medical Center | Principal Investigator |
| Rebecca Twersky, MD, MPH | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SUNY Downstate Medical Center | Brooklyn | New York | 11203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24681657 | Result | Twersky RS, Goel V, Narayan P, Weedon J. The risk of hypertension after preoperative discontinuation of angiotensin-converting enzyme inhibitors or angiotensin receptor antagonists in ambulatory and same-day admission patients. Anesth Analg. 2014 May;118(5):938-44. doi: 10.1213/ANE.0000000000000076. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 11, 2019 | |
| Reset | May 2, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 11, 2019 | May 2, 2019 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000806 | Angiotensin-Converting Enzyme Inhibitors |
| ID | Term |
|---|---|
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
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| prevalence of adverse effects (increased length of stay in the PACU, unanticipated hospitalizations, myocardial ischemia, stroke, death) | Through study completion, projected 2-3 years |
| D020164 | Chemical Actions and Uses |