Effects of low-dose esmolol on heart injury in elderly patients after surgery
Effects of Low-dose Esmolol on Myocardial Injury After Non-cardiac Surgery in Elderly Frail Patients:A Multicenter, Prospective, Double-blind, Randomized Controlled Study
This study is testing whether giving low-dose esmolol to older patients before non-heart surgery can help reduce heart injury compared to a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 2000 (estimated) |
| Ages | 65 Years to 90 Years |
| Sex | All |
| Sponsor | Qianfoshan Hospital Academic / other |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT05635877 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between preoperative frailty and myocardial injury in elderly patients undergoing non-cardiac surgery. It aims to identify predictive factors for myocardial injury and evaluate the impact of low-dose esmolol on reducing such injuries. Esmolol, a selective β-adrenergic receptor blocker, is administered to manage heart rate and reduce myocardial oxygen consumption during the perioperative period. The study will compare outcomes between patients receiving esmolol and those receiving a placebo.
Who should consider this trial
Good fit: Ideal candidates are elderly patients aged 65 and older with a modified frailty index of 0.21 or higher who are scheduled for non-cardiac surgery.
Not a fit: Patients with a history of myocardial infarction, significant cardiac insufficiency, or severe lung disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cardiac outcomes and reduced myocardial injury in frail elderly patients undergoing non-cardiac surgery.
How similar studies have performed: Previous studies have shown promising results for the use of β-blockers like esmolol in reducing perioperative myocardial ischemia, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Age ≥ 65 years;
2. ASA: ⅰ-ⅳ;
3. Modified frailty index (mFI) ≥ 0.21;
4. Patients undergoing non-cardiac surgery.
Exclusion Criteria:
1. Refuse to participate;
2. Expected hospital stay \<3 days;
3. Preoperative β-blocker therapy;
4. History of myocardial infarction or coronary artery disease;
5. Preoperative bradycardia (heart rate \[HR\] \< 50 bpm) or arrhythmia;
6. Significant cardiac insufficiency (i.e., pulmonary artery pressure \>18 mm Hg, cardiac index ≤ 2.2 L/min/m 2);
7. Severe valvular heart disease;
8. Severe lung disease (e.g. asthma or chronic obstructive pulmonary disease);
9. Patients with perioperative troponin elevation due to nonischemic causes (e.g., sepsis, pulmonary embolism, arrhythmia);
10. The same patient can only be included once, regardless of whether the reason for the second operation is related to the first cause.
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Where this trial is running
Jinan, Shandong
- Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University — Jinan, Shandong, China (Recruiting)
Study contacts
- Study coordinator: yongtao Sun, PH.D
- Email: sunyongtao1979@163.com
- Phone: 18660795201
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.