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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)

EsmololPlacebo 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)

Trial sites (1)

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

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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