RecruitingPhase 4NCT05635877

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

Effects of Low-dose Esmolol on Myocardial Injury After Non-cardiac Surgery in Elderly Frail Patients:A Multicenter, Prospective, Double-blind, Randomized Controlled Study

Sponsor

Yongtao Sun

Enrollment

2,000 participants

Start Date

Feb 7, 2023

Study Type

INTERVENTIONAL

Conditions

Myocardial Injury Frailty Esmolol

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

Min Age: 65 YearsMax Age: 90 Years

Inclusion Criteria4

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

Exclusion Criteria11

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);
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.
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Interventions

DRUGEsmolol

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

DRUGPlacebo 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.