Trial Assessing the Effect of Preoperative Furosemide on Intraoperative Blood Pressure

University of Calgary198 enrolled

Overview

The purpose of this study is to determine whether continuing or discontinuing furosemide (a diuretic) on the day of elective noncardiac surgery for those who take furosemide on a chronic basis, causes more intraoperative hypotension (low blood pressure) during surgery. Our hypothesis is that the usual practice of continuing furosemide on the day of surgery would contribute to more hypotension during surgery than discontinuing furosemide.

A significant proportion of patients who undergo surgery take medications on a chronic basis. Little is known about the effects of these medications on the successful conduct of anesthesia and surgery. Diuretics like furosemide may contribute to low blood pressure during surgery, an outcome associated with cardiovascular complications. However, many patients are recommended to take their diuretics on the day of surgery. We wished to determine if preoperative administration of furosemide contributes to intraoperative hypotension compared to placebo. Comparison: We conducted a randomized, double blind placebo controlled trial to compare the effect of furosemide with that of placebo on intraoperative hypotension using intraoperative blood pressure recordings in patients who take furosemide chronically and were undergoing noncardiac surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

198

Conditions

Hypertension Hypotension Edema Congestive Heart Failure

Interventions

furosemideDRUG

for patients on chronic furosemide therapy, patients are randomized to furosemide (at their previous dose) or placebo (given in identical form to ensure masking)

placeboDRUG

patients will be given placebo capsules (identical to experimental arm in color) at the equivalent dose as to their chronic furosemide therapy.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * All adults referred to preoperative assessment clinics by surgeons for elective non-cardiac surgery who routinely take furosemide. * Participants must also be able to give informed consent Exclusion Criteria: * Less than 18 years of age * Have comorbid conditions with which brief periods of hypotension may be particularly harmful such as: 1) pregnancy; 2) baseline hypotension (systolic \<100 mmHg at the preoperative assessment clinic); 3) autonomic dysfunction; 4) severe aortic stenosis. * Patients who take furosemide only on an 'as needed basis' rather than 'regularly'. * Those patients who take less than 10 mg of furosemide daily * Those patients who are undergoing local anesthetic only surgical procedures * Patients who are unwilling or unable to give informed consent.

Locations (3)

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Foothills Hospital

Calgary, Alberta, Canada

University of Western Ontario

London, Ontario, Canada

Outcomes

Primary Outcomes

Proportion of patients developing hypotension during the operative period. Hypotension is defined based on blood pressure criteria (systolic BP <90 mmHg or 35% drop in mean arterial pressure) (or vasopressor treatment during surgery).

Time frame: hospital stay

Secondary Outcomes

Patients will be followed up for the duration of their hospital stay for the following endpoints: (1) Development of congestive heart failure exacerbation

Time frame: hospital stay

(2) Total cardiovascular complications: composite of acute myocardial infarction, angina, stroke/TIA, arrhythmia, congestive heart failure or cardiac death.

Time frame: hospital stay

Data from ClinicalTrials.gov

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