NCT03138603.
Trial name or title | Metoprolol to reduce perioperative myocardial injury |
Methods | RCT, parallel design |
Participants |
Estimated number of recruited participants: 600 Inclusion criteria: ≥ 50 years of age; beta‐blocker naive (30 days prior to surgery); previously diagnosed coronary artery disease; history of peripheral vascular disease or chronic kidney disease; positive stress test; at risk for coronary artery disease; scheduled for major non‐cardiac, elective surgery under general anaesthesia Exclusion criteria: history of stroke, or TIA; previously diagnosed carotid disease; HR ≤ 55 bpm; congestive heart failure; severe valvular regurgitation; 2nd‐ or 3rd‐degree atrioventricular block without pacemaker; active asthma or COPD; anaemia; allergy to beta‐blockade drugs; unwilling or unable to give consent for participation; undergoing any carotid endarterectomy, endovascular, endoscopic, superficial, or ambulatory procedures; pregnancy or lactating women; prisoners Country: USA Setting: hospital; single centre |
Interventions | Metoprolol: up to 3 IV doses of IV metoprolol tartrate 5 mg prior to extubation, and subsequently an oral dose 25 mg metoprolol tartrate in the PACU, and then oral dosing at approximately every 8 h thereafter up to postoperative day 3 Placebo: given same as the intervention group |
Outcomes |
Outcomes measured/reported by study authors: myocardial injury; MACE; myocardial ischaemia (ST‐depression/elevation duration); stroke; cumulative vasopressor requirements in PACU; incidence rate bradycardia duration (HR < 50/min); cumulative rate bradycardia duration (HR < 50/min); unplanned ICU admission; length of hospital stay; length of ICU stay Outcomes relevant to the review: stroke; length of hospital stay |
Starting date | December 2016 |
Contact information | Principal Investigator: Peter Nagele, MD, Washington University School of Medicine |
Notes |
AAA: abdominal aortic aneurysm; AHA/ACC: American Heart Association/American College of Cardiology; BP: blood pressure; bpm: beats per minute; COPD: chronic obstructive pulmonary disorder; ECG: electrocardiography; GA: general anaesthesia; HR: heart rate; ICU: intensive care unit; IV: intravenous(ly); MACE: major adverse cardiovascular event; PTSD: post‐traumatic stress disorder; PACU: post‐anaesthesia care unit; RCT: randomized controlled trial; TIA: transient ischaemic attack