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AzTrials

FrailtyPhase 4NCT05635877

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

A Phase 4 study testing Esmolol in people with Frailty and Esmolol, run by Yongtao Sun at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 65 to 90 years
Conditions the study is for
Frailty, Esmolol, Myocardial Injury
What is being tested?
Esmolol
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,000 participants
Where
1 siteChina
Study dates
7 Feb 2023to 30 Dec 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 90 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Age ≥ 65 years;
  • ASA: ⅰ-ⅳ;
  • Modified frailty index (mFI) ≥ 0.21;
  • Patients undergoing non-cardiac surgery.

Who cannot join

  • Refuse to participate;
  • Expected hospital stay <3 days;
  • Preoperative β-blocker therapy;
  • History of myocardial infarction or coronary artery disease;
  • Preoperative bradycardia (heart rate [HR] < 50 bpm) or arrhythmia;
  • Significant cardiac insufficiency (i.e., pulmonary artery pressure >18 mm Hg, cardiac index ≤ 2.2 L/min/m 2);
Show all 11Show fewer
  • Severe valvular heart disease;
  • Severe lung disease (e.g. asthma or chronic obstructive pulmonary disease);
  • Patients with perioperative troponin elevation due to nonischemic causes (e.g., sepsis, pulmonary embolism, arrhythmia);
  • The same patient can only be included once, regardless of whether the reason for the second operation is related to the first cause.
  • -

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

yongtao Sun, PH.D contact

18660795201

sunyongtao1979@163.com

China1 site, 1 recruiting

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

    Jinan, Shandong

    Sun Y tao, pH.D, 18660795201, sunyongtao1979@163.com

    Recruiting

Other trials in China

About this study

Official title: 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 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.
Read the 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.

Being tested
Esmolol, Placebo Comparator: Placebo Comparator:normal saline(0.9%)
Keywords
myocardial injury after non-cardiac surgery, MINS
Medical subject headings
Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EsmololDrug

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

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

Study groups in NCT05635877
Study groupRoleWhat they receive
Experimental:EsmololExperimentalThe 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.
Receives: Drug: Esmolol
Placebo Comparator:normal saline(0.9%)Placebo comparatorThe 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.
Receives: Drug: Placebo Comparator: Placebo Comparator:normal saline(0.9%)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. incidence of Postoperative myocardial injury after non-cardiac surgery(MINS)

    incidence of Postoperative myocardial injury after non-cardiac surgery（MINS）, blood samples were collected at 1 day before surgery and 1, 2, and 3 days after surgery.

    MINS diagnostic criteria: Blood samples were collected before surgery, 1d, 2d and 3d after surgery for Roche fourth-generation Elecsys hs-TnT detection, cardiac troponin（cTnT） ≥ 0.03 ng/mL, and MINS can be diagnosed.

    Measured: incidence of MINS within 3 days after operation

Secondary outcomes (1)

  1. the results of 30 days after surgery

    the results of 30 days after surge, demographic characteristics of patients, preoperative disease complications, the treatments number of intraoperative hemodynamic instability , hospital stays, any complications occurring within 30 days after surgery, and readmitted to hospital were recorded.

    Perioperative MAP < 65 mmHg or bradycardia (HR) < 50 times /min in both groups, and no spontaneous remission was found 5 minutes after the operation was stopped, that is, intervention measures were given, including ephedrine, atropine, dopamine and other treatments., demographic characteristics of patients, preoperative disease complications, the number of intraoperative hemodynamic instability treatments, length of stay, any complications occurring within 30 days after surgery, and readmitted to hospital were recorded.

    Measured: Outcomes at 30 days after operation were recorded

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2022
  2. Study start7 Feb 2023
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05635877
Sponsor's protocol ID
20221028YTsun
Status last verified
Mar 2023
First submitted
3 Nov 2022
Last updated
29 Mar 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 38504166

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Esmolol in people with Frailty and Esmolol, run by Yongtao Sun at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact yongtao Sun, PH.D (18660795201, sunyongtao1979@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

incidence of Postoperative myocardial injury after non-cardiac surgery(MINS) (time frame: incidence of MINS within 3 days after operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05635877, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023; AzTrials last refreshed its copy on 8 Nov 2026.

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