- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05635877
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
This topic will focus on the following questions:
- 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.
- Part Two: To explore the effect of low-dose esmolol on myocardial injury after non-cardiac surgery in frail elderly patients.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: yongtao Sun, PH.D
- Phone Number: 18660795201
- Email: sunyongtao1979@163.com
Study Locations
-
-
Shandong
-
Jinan, Shandong, China
- Recruiting
- Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
-
Contact:
- Sun Y tao, pH.D
- Phone Number: 18660795201
- Email: sunyongtao1979@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age ≥ 65 years;
- ASA: ⅰ-ⅳ;
- Modified frailty index (mFI) ≥ 0.21;
- Patients undergoing non-cardiac surgery.
Exclusion Criteria:
- 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.
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental:Esmolol
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incidence of Postoperative myocardial injury after non-cardiac surgery(MINS)
Time Frame: incidence of MINS within 3 days after operation
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the results of 30 days after surgery
Time Frame: Outcomes at 30 days after operation were recorded
|
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. |
Outcomes at 30 days after operation were recorded
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20221028YTsun
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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