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Effect of perioperative infusion of dexmedetomidine on myocardial injury after major orthopedic surgery in patients with high risk of cardiovascular disease: A randomized controlled trial

Effect of perioperative infusion of dexmedetomidine on myocardial injury after major orthopedic surgery in patients with high risk of cardiovascular disease: A randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054784
Enrollment
Unknown
Registered
2021-12-27
Start date
2022-06-01
Completion date
Unknown
Last updated
2022-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial injury

Interventions

Experimental group:Dexmedetomidine (0.5µg/kg/h) was infused before surgery, postoperative dexmedetomidine adjuvant patient-controlled intravenous analgesia (0.05µg/kg/hr, single dose 0.05µg/kg, lock-i
Control group:Infusion of the same amount of normal saline

Sponsors

Fuzhou Second Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. >=45 years old; 2. Major orthopedic surgery under elective general anesthesia, including total hip replacement, total knee replacement and other hip surgeries, is expected to require more than 2 days of hospitalization after surgery; 3. Patients with high cardiovascular risk in the perioperative period, that is, at least one of the following conditions: history of stroke: a clear history of stroke in the past, or imaging examinations suggest a previous stroke. History of coronary heart disease: past definite history of angina pectoris, myocardial infarction, or abnormal wall motion on echocardiography, or more than 50% lumen stenosis on coronary angiography, or pathological pathology in two or more adjacent leads on electrocardiogram Q wave. History of cardiac insufficiency: The subject must be diagnosed with cardiac insufficiency during the current or previous hospitalization, and have corresponding symptoms or signs within 30 days before surgery. History of aortic or peripheral arterial vascular disease: a clear history of peripheral arterial disease, or ischemic intermittent claudication or rest pain, or history of lower extremity revascularization surgery, or peripheral arterial lumen stenosis of more than 50%. Preoperative NT-proBNP>=300 ng/L or BNP>=92 mg/L. Preoperative hs-TnT or cTnI > upper limit of normal reference range: with >= 2 of the following risk factors: (1) Age 65 and above; (2) Hypertension treated with drugs (or not using drugs but not up to the standard, excluding those who are well controlled by simple exercise or diet therapy); (3) Diabetes treated by drugs (or those who do not use drugs but are not well controlled, excluding those who are well controlled by simple exercise or diet therapy); (4) Chronic kidney disease (preoperative serum creatinine >=133 µmol/L or 1.5 mg/dL); (5) History of transient ischemic attack; (6) Continued smoking (interrupted less than 1 month) for 2 years or more before this admission, (70 hypercholesterolemia (preoperative serum total cholesterol >= 6mmol/L or receiving cholesterol-lowering drug therapy).

Exclusion criteria

Exclusion criteria: 1. ASA classification V and above; 2. End-stage renal disease requiring (or undergoing) renal replacement therapy; 3. Acute cardiovascular and cerebrovascular events (including acute heart failure, acute coronary syndrome, and stroke within the past 1 month); 4. Preoperative diagnosis of sepsis; 5. Sick sinus syndrome without pacemaker; 6. II or III degree atrioventricular block; 7. History of bradycardia with clinical symptoms; 8. Contraindications to the use of a2-agonists; 9. Significant liver dysfunction, such as twice the normal level (at the discretion of the investigator); 10. Allergy to dexmedetomidine or similar drugs; 11. Participated in this research; 12. Participating in another interventional clinical study; 13. Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Incidence of myocardial injury after non-cardiac surgery;

Secondary

MeasureTime frame
Incidence of major cardiovascular events 30 days after surgery;30-day all-cause mortality postoperatively;Incidence of major non-cardiovascular events 30 days after surgery;Survival 1 year postoperatively;The number of days that patients survived without hospitalization within 30 days;

Countries

China

Contacts

Public ContactChen Xiaomei

Fuzhou Second Hospital

zzs201@163.com+86 13906906016

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026