Primary research hypothesis: Patients who continue their chronic ACEI therapy up to and including the morning of a non-cardiac, non-vascular surgery will experience more intraoperative hypotension than those who transiently hold their chronic ACEI preoperatively. Secondary research hypothesis #1: Patients who continue their chronic ACEI up to and including the morning of a non-cardiac, non-vascular surgery will experience better postoperative control of hypertension than those who transiently hold their chronic ACEI preoperatively. Secondary research hypothesis #2: Patients who continue their chronic ACEI up to and including the morning of a non-cardiac, non-vascular surgery will experience less acute renal failure than those who transiently hold their chronic ACEI preoperatively. Secondary research hypothesis #3: In the subgroup of patients with a preoperative systolic blood pressure less than 110 mmHg, those who continue their chronic ACEI therapy up to and including the morning of a non-cardiac, non-vascular surgery will experience more intraoperative hypotension than those who transiently hold their chronic ACEI preoperatively. Secondary research hypothesis #4: In the subgroup of patients above the age of 64, those who continue their chronic ACEI therapy up to and including the morning of a non-cardiac, non-vascular surgery will experience more intraoperative hypotension than those who transiently hold their chronic ACEI preoperatively.
The purpose of this study is to determine if transient discontinuation of angiotensin converting enzyme inhibitors (ACEIs) is necessary prior to non-cardiac, non-vascular surgery. ACEIs have been associated with intraoperative hypotension during vascular and cardiac surgeries. Patients presenting to the University of Nebraska Medical Center Pre-Anesthesia Screening (PAS) Clinic who are on chronic ACEI therapy will be eligible for enrollment. Subjects will be randomized to either omit or continue their ACEI preoperatively. The outcome of interest is intraoperative hypotension defined as a systolic blood pressure less than 80 mmHg. Blood pressure will be followed not only throughout surgery, but also during recovery and the remainder of hospitalization. Renal function will be assessed with creatinine measurements in the PAS clinic and on the first postoperative day. No follow-up is planned beyond discharge from the hospital.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
291
These chronic medications will be taken without interruption preoperatively.
Although taken chronically by patients in this intervention, the final preoperative dose of these medications will be omitted, whether it was scheduled for the morning of surgery or the day prior.
University of Nebraska Medical Center
Omaha, Nebraska, United States
Number of Participants With Interoperative Hypotension
Number of Participants with Interoperative Hypotension (systolic blood pressure under 80 mmHg)
Time frame: During anesthesia, an expected average of 3 hours.
Acute Renal Failure
Creatinine increase of more than 0.3 mg/dl or more than 50% from preoperative level
Time frame: Arrival in post-anesthesia care unit (PACU) to hospital discharge, an expected average of 4 days.
Low Blood Pressure Subgroup
Only patients with systolic blood pressure less than 110 at preoperative evaluation will be included in this analysis. The outcome is the same as the primary outcome: Intraoperative Systolic Blood Pressure under 80 mmHg.
Time frame: During anesthesia, an expected average of 3 hours.
Older Age Subgroup
Only patients above the age of 64 will be included in this analysis. The outcome is the same as the primary outcome: Intraoperative Systolic Blood Pressure under 80 mmHg
Time frame: During anesthesia, an expected average of 3 hours.
Postoperative Hypertension
Any systolic blood pressure greater than 180 mmHg.
Time frame: Arrival in PACU to hospital discharge, an expected average of 4 days.
Postoperative Hypotension
Any systolic blood pressure less than 90 mmHg
Time frame: Arrival in PACU to hospital discharge, an expected average of 4 days.
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