Clinical trial

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

Name

20221028YTsun

Description

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.

Trial arms

Trial start

2023-02-07

Estimated PCD

2026-11-30

Trial end

2026-12-30

Status

Recruiting

Phase

Early phase I

Treatment

Esmolol

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

Arms:

Experimental:Esmolol

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.

Arms:

Placebo Comparator:normal saline(0.9%)

Size

2000

Primary endpoint

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

incidence of MINS within 3 days after operation

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. -

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 2000, 'type': 'ESTIMATED'}}

Updated at

2023-03-29

1 organization

2 products

3 indications

Organization

Product

Indication

Indication

Indication

Product