Tight pressure management: Norepinephrine or phenylephrine infusion to maintain intraoperative MAP ≥85 mmHg, delayed resumption of chronic antihypertensive medications, and a target ward MAP ≥80 mmHg (tight pressure management)
Routine pressure management: Routine intraoperative blood pressure management and immediate restart of antihypertensive medications.
Study summary
The treatments will be: 1) norepinephrine or phenylephrine infusion to maintain intraoperative MAP ≥85 mmHg, delayed resumption of chronic antihypertensive medications, and a target ward MAP ≥80 mmHg (tight pressure management); or, 2) routine intraoperative blood pressure management and prompt resumption of chronic antihypertensive medications (routine pressure management).
Eligibility
Sex
ALL
Min age
45 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* ≥45 years old
* Scheduled for major noncardiac surgery expected to last at least 2 hours;
* Having general endotracheal, neuraxial anesthesia, or the combination;
* Expected to require at least overnight hospitalization;
* 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 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:
* 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;
* B-type natriuretic protein (BNP) \>80 ng/L or N-terminal B-type natriuretic protein (NT-ProBNP) \>100 ng/L
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.
Primary outcome measure(s)
Intraoperative blood pressure management — Intraoperative The fraction of time when intraoperative MAP is \<65 mmHg and ≥85 mmHg during surgery.
Postoperative blood pressure management — First 3 postoperative days Time to restarting routine antihypertensive medications.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.