Abstract
Background: Older hypertensive adults are at increased risk for postoperative morbidity and mortality. As first line antihypertensive drug therapy, angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) have many beneficial effects. However, the use of ACEIs/ARBs in the perioperative period remains controversial. This study aims to determine the effects of withholding vs. continuing ACEIs/ARBs before non-cardiac surgery on perioperative hypotension and postoperative outcomes in older patients.Methods: In this multicenter, randomized, double-blind, placebo-controlled trial, a total of 2036 patients aged 60–80 years undergoing non-cardiac surgical procedures will be randomly assigned, in a 1:1 ratio, to receive oral ACEIs/ARBs (the ACEIs/ARBs continued group) or inactive placebos (the ACEIs/ARBs withheld group) on the morning of surgery. For both groups, the ACEIs/ARBs will be continued from the first postoperative day. The primary outcome measure is the incidence of perioperative hypotensive events, defined as mean blood pressure (MBP) < 65 mmHg or ≥30% reduction in MBP from baseline during surgery and in a post-anesthesia care unit. The secondary outcomes include duration of perioperative hypotension, intraoperative use of fluids and vasopressors, hypotensive events within postoperative 3 days, and perioperative neurocognitive disorders, major adverse cardiocerebral events (a composite outcome of stroke, coma, myocardial infarction, heart block, and cardiac arrest), and mortality within 30 days after surgery.Discussion: The results of this trial will offer an evidence-based perioperative ACEIs/ARBs therapy for older hypertensive adults undergoing non-cardiac surgery.Study Registration: This study is approved by the Medical Ethics Committee of The First Affiliated Hospital of Soochow University (Approval No. 2020-077-1) and by the institutional ethics review board of each participating center. This protocol is registered at the Chinese Clinical Trials Registry (ChiCTR2000039376).
Highlights
The era of geriatric surgery has arrived [1, 2]
The primary outcome measure of this trial is the incidence of perioperative hypotensive events, defined as mean blood pressure (MBP) < 65 mmHg or ≥30% reduction in MBP from baseline for which an intervention is needed, which occur during surgery and in the postanesthesia care unit (PACU)
The exploratory outcomes are as follows: [1] the incidence of hypertensive events (MBP > 110 mmHg or ≥ 30% increase in MBP from baseline) during surgery, in the PACU, and within 3 postoperative days, [2] tachycardia or bradycardia events defined as heart rate (HR) > 100 beats/min or HR < 50 beats/min, [3] intraoperative adverse events, [4] Ramsay sedation scores in the PACU, [5] numerical rating scale scores for pain, analgesic consumption, and postoperative nausea and vomiting (PONV) in the PACU and in the wards within three post-operative days, [6] time to extubation, [7] intensive care unit (ICU) admission, and [8] length of postoperative hospital stay
Summary
The era of geriatric surgery has arrived [1, 2]. With a rapidly aging global population, increasing numbers of surgical operations are being performed on older adults. As first line antihypertensive treatment, angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) produce arterial vasodilatation and reduce blood pressure through the inhibition of the renin–angiotensin aldosterone system [4]. The use of ACEIs/ARBs exerts many beneficial effects, including improved cardiovascular and renal outcomes in patients with diabetes, decreased mortality in patients with acute kidney injury, and improvement in symptoms and survival in patients with heart failure with reduced ejection fraction [7,8,9,10]. Older hypertensive adults are at increased risk for postoperative morbidity and mortality. This study aims to determine the effects of withholding vs continuing ACEIs/ARBs before non-cardiac surgery on perioperative hypotension and postoperative outcomes in older patients
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