ACEI/ARB Study in Ambulatory and Day of Surgery Admission Patients

NCT ID: NCT03121092

Last Updated: 2017-04-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 188 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-16
• Study Completion Date: 2017-03-07

Brief Summary

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.

Conditions

Hypertension; Hypotension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Discontinue ACEI or ARB

Patients in this group will not take the ACE or ARB 24 hours prior to their procedure.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Continue ACEI or ARB

Patients in this group will take an ACE or ARB on the day of surgery.

Group Type: ACTIVE_COMPARATOR

ACEI or ARB

Intervention Type: DRUG

Angiotensin converting enzyme inhibitors (ACEI's) and Angiotensin receptor blockers (ARB's) - commonly used anti-hypertensive medications

Interventions

ACEI or ARB

Angiotensin converting enzyme inhibitors (ACEI's) and Angiotensin receptor blockers (ARB's) - commonly used anti-hypertensive medications

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• patients over the age of 18
• patients scheduled to undergo any surgical procedure on an ambulatory basis or on a same day admission basis
• patients undergoing general anesthesia by Laryngeal Mask Airway (LMA)
• patients taking chronic ACEI or ARB drug treatment for hypertension for more than 6 weeks
• patients on diuretics and/or beta blockers and/or calcium channel blockers for hypertension in addition to the ACEI or ARB (alone or in combination) for hypertension may be included
• patients taking any cardiovascular medications may be included

Exclusion Criteria

• patients taking both an ACEI and an ARB simultaneously
• patients taking ACEI or ARB for less than 6 weeks
• patients with uncontrolled hypertension during pre-surgical testing (PST) visit, defined as Systolic (SBP) > 180 or Diastolic (DBP) > 100 (Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure JNC 7)
• patients with history of unstable heart disease, refractory congestive heart failure, hypertensive stroke, mini stroke, stroke or heart attack within the past 6 months
• emergency surgery
• patients who are pregnant
• patients whose surgery requires endotracheal intubation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

State University of New York - Downstate Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ketan Shevde, MD

Role: PRINCIPAL_INVESTIGATOR

State University of New York - Downstate Medical Center

Rebecca Twersky, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

SUNY Downstate Medical Center

Brooklyn, New York, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 24681657 (View on PubMed)

Other Identifiers

303066-1

Identifier Type: -

Identifier Source: org_study_id