Effects of Low-dose Esmolol on Myocardial Injury After Non-cardiac Surgery in Elderly Frail Patients
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age65-90
SponsorYongtao Sun
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 65 years;
ASA: ⅰ-ⅳ;
Modified frailty index (mFI) ≥ 0.21;
Patients undergoing non-cardiac surgery.
Disqualifiers
Refuse to participate;
Expected hospital stay <3 days;
Preoperative β-blocker therapy;
History of myocardial infarction or coronary artery disease;
Trial design
Design model
Parallel
Treatments tested in this trial
Esmolol
DrugThe treatment group was given Esmolol 0.5mg/kg load and 10μg /kg/min continuous pump
Placebo Comparator: Placebo Comparator:normal saline(0.9%)
DrugThe 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.
Treatment groups
2,000 Participants
are divided into 2 treatment groupsGroup A: Experimental:EsmololExperimental treatment 1 intervention
Group B: Placebo Comparator:normal saline(0.9%)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
incidence of MINS within 3 days after operationSecondary outcomes
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.
Time frame
Outcomes at 30 days after operation were recordedSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yongtao Sun
Lead sponsor
Qianfoshan Hospital
Sponsor institution
Source ClinicalTrials.gov