Comparing Etomidate and Propofol for Anesthesia in Major Surgery

GUARDIAN (NCT04884802) Sub-study Comparing Etomidate and Propofol

This study is testing whether using etomidate or propofol for anesthesia helps older patients with certain health risks have better outcomes during major surgery.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 6254 (estimated)
• Ages: 45 Years and up
• Sex: All
• Sponsor: The Cleveland Clinic (Academic / other)
• Locations: 1 site (Cleveland, Ohio)
• Trial ID: NCT04934683 on ClinicalTrials.gov

What this trial studies

This clinical trial is a sub-study of the GUARDIAN trial, focusing on patients undergoing major noncardiac surgery. Participants will be randomized to receive either etomidate or propofol for anesthetic induction, in addition to being assigned to routine or tight intraoperative blood pressure management. The study aims to evaluate the effects of these anesthetic agents on patient outcomes during surgery. It involves patients who are at least 45 years old and have specific risk factors that may affect their anesthesia management.

Who should consider this trial

Good fit: Ideal candidates are patients aged 45 and older scheduled for major noncardiac surgery with specific health risk factors.

Not a fit: Patients who are not undergoing major surgery or do not meet the age and health criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve anesthesia practices and patient safety during major surgeries.

How similar studies have performed: Previous studies have shown varying success with different anesthetic agents, but this specific comparison is novel.

Eligibility criteria

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.

Where this trial is running

Cleveland, Ohio

• Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Daniel I Sessler, MD — The Cleveland Clinic
• Study coordinator: Fabio Rodriquez Patarroyo, MD

Conditions Major Surgery