GUARDIAN (NCT04884802) Sub-study Etomidate vs Propofol

  • STATUS
    Recruiting
  • End date
    Jul 9, 2025
  • participants needed
    6254
  • sponsor
    The Cleveland Clinic
Updated on 9 August 2021

Summary

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:

  1. routine intraoperative blood pressure management and prompt resumption of chronic antihypertensive medications (routine pressure management); or 2) norepinephrine or phenylephrine infusion to maintain intraoperative MAP 85 mmHg, delayed resumption of chronic antihypertensive medications, and a target ward systolic pressure of at least 110 mmHg (tight pressure management). Patients participating in this sub-study will be additionally randomized to etomidate or propofol for induction of anesthesia.

Details
Condition Major Surgery
Treatment Propofol, Etomidate, Routine blood pressure control, Tight blood pressure control
Clinical Study IdentifierNCT04934683
SponsorThe Cleveland Clinic
Last Modified on9 August 2021

Eligibility

Yes No Not Sure

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 mol/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14 ng/L or troponin I equivalent, defined as 15 ng/L (Abbott assay),77 19 ng/L (Siemens assay, [Borges, unpublished]), or 25% of the 99% percentile for other assays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
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