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

NCT05635877 | Recruiting Phase 4

• 1 other identifier: 20221028YTsun
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

This topic will focus on the following questions:

1. 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. 2.Part Two: To explore the effect of low-dose esmolol on myocardial injury after non-cardiac surgery in frail elderly patients.

Conditions

Frailty; Esmolol; Myocardial Injury

Keywords

myocardial injury after non-cardiac surgery, MINS

Outcome Measures

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.

  incidence of MINS within 3 days after operation

Secondary Outcomes (1)

• the results of 30 days after surgery

  Outcomes at 30 days after operation were recorded

Study Arms (2)

Experimental:Esmolol

EXPERIMENTAL

The treatment group was given esmolol 0.5mg/kg load, 10μg /kg/min continuous pump; 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.

Drug: Esmolol

Placebo Comparator:normal saline(0.9%)

PLACEBO COMPARATOR

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.

Drug: Placebo Comparator: Placebo Comparator:normal saline(0.9%)

Interventions

Esmolol DRUG

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

Experimental:Esmolol

Placebo Comparator: Placebo Comparator:normal saline(0.9%) DRUG

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.

Placebo Comparator:normal saline(0.9%)

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yongtao Sun: lead

Study Sites (1)

Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University

Jinan, Shandong, China

RECRUITING

Related Publications (1)

• Sun Y, Guo N, Zhang M, Liu M, Gao Z, Sun T, Gao X, Xu L, Zhang H, Wei C, Liu P, Liu Y, Zhang X, Guo Y, Chen L, Zhou Z, Su Z, Hu Y, Shi X, Huang L, Wang Y. Association between preoperative frailty and myocardial injury after noncardiac surgery in geriatric patients: study protocol for a prospective, multicentre, real-world observational, cohort trial. BMC Geriatr. 2024 Mar 19;24(1):271. doi: 10.1186/s12877-024-04847-z.

  PMID: 38504166 DERIVED

MeSH Terms

Conditions

Frailty

Interventions

esmolol

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

yongtao Sun, PH.D

CONTACT

18660795201; sunyongtao1979@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: December 2, 2022
• Study Start: February 7, 2023
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 29, 2023

Record last verified: 2023-03

Locations

CN (1)