Effects of Low-dose Esmolol on Myocardial Injury After Non-cardiac Surgery in Elderly Frail Patients

NCT ID: NCT05635877

Last Updated: 2023-03-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 2000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-07
• Study Completion Date: 2026-12-30

Brief Summary

This topic will focus on the following questions:

1. Part one: To clarify the relationship between preoperative frailty and myocardial injury (cTnT ≥0.03) after non-cardiac surgery in elderly patients; To further explore the predictive factors of myocardial injury after non-cardiac surgery （MINS） in elderly frail patients before operation.

2. Part Two: To explore the effect of low-dose esmolol on myocardial injury after non-cardiac surgery in frail elderly patients.

Detailed Description

Esmol is a short-acting selective β-adrenergic receptor blocker, which is often used in patients with cardiovascular diseases or hypertension. It is also used to reduce stress response, control heart rate and reduce myocardial oxygen consumption during perioperative period to effectively protect cardiac function. However, the safety and efficacy of perioperative β-blockers are still controversial due to their possible effects on renal function. Several recent studies have shown that β-blockers reduce perioperative myocardial ischemia and may reduce the risk of perioperative myocardial infarction (PMI) and cardiovascular death in high-risk patients . The 2021 American College of Cardiology /American Heart Association (ACC/AHA )guidelines for coronary revascularization suggest that dose adjustment can optimize the clinical effects of β-blockers, thereby reducing adverse effects during treatment . In addition, several studies have found that continuous intraoperative infusion of low-dose esmolol (5-10μg/kg/min) can reduce intraoperative stress response and maintain hemodynamic stability. The meta-analysis of esmolol by Ollila A et al. found that esmolol has a promising application in the prevention of perioperative myocardial ischemia and serious complications associated with long-term ischemia. Does perioperative Esmolol reduce the incidence of myocardial injury after non-cardiac surgery （MINS）? The safety, outcome and benefit of perioperative esmolol in frail patients are still unclear. Therefore, this study intends to apply the appropriate dose of esmolol to prevent cardiovascular events in elderly frailty patients undergoing non-cardiac surgery, and explore the effect of low-dose esmolol on MINS in elderly frail patients, so as to provide feasible clinical measures for the safe outcome and rehabilitation of frail patients during perioperative period.

Conditions

Frailty; Esmolol; Myocardial Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Experimental:Esmolol

The treatment group was given esmolol 0.5mg/kg load, 10μg /kg/min continuous pump; Patient-controlled analgesia pump (sufentanil 2 μg/kg, 2 mL/h, for 48h) was used as the postoperative analgesia regimen in the two groups. If the VAS score was \>3, analgesic adjuvant drugs were given intravenously and recorded. If repeated treatment is ineffective, the study will be excluded.

Group Type: EXPERIMENTAL

Esmolol

Intervention Type: DRUG

The treatment group was given Esmolol 0.5mg/kg load and 10μg /kg/min continuous pump

Placebo Comparator:normal saline(0.9%)

The control group received the same volume of 0.9% normal saline, which was continuously pumped until the end of the operation before extubation.Patient-controlled analgesia pump (sufentanil 2 μg/kg, 2 mL/h, for 48h) was used as the postoperative analgesia regimen in the two groups. If the VAS score was \>3, analgesic adjuvant drugs were given intravenously and recorded. If repeated treatment is ineffective, the study will be excluded.

Group Type: PLACEBO_COMPARATOR

Placebo Comparator: Placebo Comparator:normal saline(0.9%)

Intervention Type: DRUG

The control group received the same volume of 0.9% normal saline, which was continuously pumped until the end of the operation before extubation.Patient-controlled analgesia pump (sufentanil 2 μg/kg, 2 mL/h, for 48h) was used as the postoperative analgesia regimen in the two groups. If the VAS score was \>3, analgesic adjuvant drugs were given intravenously and recorded. If repeated treatment is ineffective, the study will be excluded.

Interventions

Esmolol

The treatment group was given Esmolol 0.5mg/kg load and 10μg /kg/min continuous pump

Intervention Type: DRUG

Placebo Comparator: Placebo Comparator:normal saline(0.9%)

The control group received the same volume of 0.9% normal saline, which was continuously pumped until the end of the operation before extubation.Patient-controlled analgesia pump (sufentanil 2 μg/kg, 2 mL/h, for 48h) was used as the postoperative analgesia regimen in the two groups. If the VAS score was \>3, analgesic adjuvant drugs were given intravenously and recorded. If repeated treatment is ineffective, the study will be excluded.

Intervention Type: DRUG

Eligibility 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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• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yongtao Sun

OTHER

Sponsor Role: lead

Responsible Party

Yongtao Sun

professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

yongtao Sun, PH.D

Role: CONTACT

sunyongtao1979@163.com

18660795201

Facility Contacts

Sun Y tao, pH.D

Role: primary

sunyongtao1979@163.com

18660795201

References

Sun Y, Guo N, Zhang M, Liu M, Gao Z, Sun T, Gao X, Xu L, Zhang H, Wei C, Liu P, Liu Y, Zhang X, Guo Y, Chen L, Zhou Z, Su Z, Hu Y, Shi X, Huang L, Wang Y. Association between preoperative frailty and myocardial injury after noncardiac surgery in geriatric patients: study protocol for a prospective, multicentre, real-world observational, cohort trial. BMC Geriatr. 2024 Mar 19;24(1):271. doi: 10.1186/s12877-024-04847-z.

Reference Type: DERIVED

PMID: 38504166 (View on PubMed)

Other Identifiers

20221028YTsun

Identifier Type: -

Identifier Source: org_study_id