Overview
Some patients participating in the underlying GUARDIAN trial (NCT04884802) will be additionally randomized to etomidate vs propofol for anesthetic induction.
Description
Patients participating in the underlying GUARDIAN trial (NCT04884802) will be randomized to:
- routine intraoperative blood pressure management (routine pressure management); or 2) norepinephrine or phenylephrine infusion to maintain intraoperative MAP ≥85 mmHg (tight pressure management). Patients participating in this sub-study will be additionally randomized to etomidate or propofol for induction of anesthesia.
Eligibility
Inclusion Criteria:
- At least 45 years old;
- Scheduled for major noncardiac surgery expected to last at least 2 hours;
- Having general anesthesia, neuraxial anesthesia, or the combination;
- Expected to require at least overnight hospitalization (planned ICU admission is acceptable);
- Are designated ASA physical status 2-4 (ranging from mild systemic disease through severe systemic disease that is a constant threat to life);
- Chronically taking at least one anti-hypertensive medication;
- Expected to have direct intraoperative blood pressure monitoring with an arterial catheter;
- Cared for by clinicians willing to follow the GUARDIAN protocol;
- Subject to at least one of the following risk factors:
- Age >65 years;
- History of peripheral arterial surgery;
- History of coronary artery disease;
- History of stroke or transient ischemic attack;
- Serum creatinine >175 µmol/L (>2.0 mg/dl);
- Diabetes requiring medication;
- Current smoking or 15 pack-year history of smoking tobacco;
- Scheduled for major vascular surgery;
- Body mass index ≥35 kg/m2;
- Preoperative high-sensitivity troponin T >14 ng/L or troponin I equivalent, defined as ≥15 ng/L (Abbott assay),77 19 ng/L (Siemens assay, [Borges, unpublished]), or 25% of the 99% percentile for other assays;
- B-type natriuretic protein (BNP) >80 ng/L or N-terminal B-type natriuretic protein (NT-ProBNP) >200 ng/L.78,79
Exclusion Criteria:
- Are scheduled for carotid artery surgery;
- Are scheduled for intracranial surgery;
- Are scheduled for partial or complete nephrectomy;
- Are scheduled for pheochromocytoma surgery;
- Are scheduled for liver transplantation;
- Require preoperative intravenous vasoactive medications;
- Have a condition that precludes routine or tight blood pressure management such as surgeon request for relative hypotension;
- Require beach-chair positioning;
- Have end-stage renal disease requiring dialysis or estimated glomerular filtration rate (eGFR) <30 ml/min;
- Have a documented history of dementia;
- Have language, vision, or hearing impairments that may compromise cognitive assessments;
- Have contraindications to norepinephrine or phenylephrine per clinician judgement;
- Have previously participated in this trial.