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Clinical Trials in China / NCT05635877
Recruiting Phase 4

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

NCT05635877 · tracked via the Priya Life Science China tracker
Sponsor
Yongtao Sun
Phase
Phase 4
Started
2023-02-07
Last updated
2023-03-29

Condition(s) studied

FrailtyEsmololMyocardial Injury

Investigational drug(s) / intervention(s)

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

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

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.

Study 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.

Eligibility

Sex
ALL
Min age
65 Years
Max age
90 Years
Healthy volunteers
No
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. \-

Primary outcome measure(s)

  • incidence of Postoperative myocardial injury after non-cardiac surgery(MINS) — incidence of MINS within 3 days after operation
    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.

Trial sites (1)

FacilityCityRegionStatus
Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University Jinan Shandong Recruiting

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The Impact of Automatic Lung Recruitment Postoperative Pulmonary Complications Starting soon

Other trials for the same condition

The Effect of Remote Ischemic Preconditioning on Myocardial Injury After Noncardiac Surgery Active, not recruiting
The Relationship Between Preoperative Frailty and Postoperative AKI and the Mediating Effect of Intraoperative BP Recruiting
Individualized Dynamic Frailty-tailored Therapy (DynaFiT) in Elderly Patients With NDMM Recruiting
Silkworm Pupa Powder Improves Alzheimer's Disease Starting soon
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Myocardial Injury in Elderly Patients Undergoing Thoracoscopic Surgery: a Prospective, Randomized Controlled Study Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05635877 on ClinicalTrials.gov ↗ ← All trials in China