Sufentanil in Patients With Lower Extremity Fracture Surgery Myocardial Damage Function Study (Sipwlefsmdfs)

Shanxi Medical University

Status: Not yet enrolling

Conditions: Myocardial Injury

Treatments: Drug: Sufentanil injection; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06808841

Gz20250110

Details and patient eligibility

About

1. To analyze the association of different doses of opioids on myocardial injury/protection through BMP-6/SMAD pathway.
2. To observe the effect of different doses of opioids on the expression of BMP-6 in bone marrow.
3. To investigate the relationship between different doses of opioids and BMP-6 and perioperative cardiovascular adverse events in patients with lower extremity fracture surgery.

Full description

This study explored the important role of BMP6/SMAD pathway in myocardial/injury protection by observing the effects of different doses of opioids on myocardial injury indexes hs-cTnI and BMP-6 related indexes in patients undergoing lower extremity fracture surgery, as well as the changes of BMP6 expression in bone marrow tissue of fracture end. The relationship between different doses of opioids and BMP6 and cardiac adverse events provides a theoretical basis for clinical rational drug use.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• There were 160 patients aged 18-65 years and older who needed surgery for lower extremity fracture.
• ASA grades I to III, gender is not limited.

Exclusion criteria

• Patients with acute myocardial infarction in the last 6 months, those with a history of heart failure, and those with elevated troponin levels before injury.
• Old fracture
• Stroke patients
• Liver cirrhosis, kidney failure
• Serious systemic infections, alcoholism, drug dependence
• Pathological fracture
• Use of glucocorticoids in the past one month
• Diabetic

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 4 patient groups

Low dose sufentanil group

Experimental group

Description:

The concentration of sufentanil is set to concentration for the low-dose group

Treatment:

Drug: Sufentanil injection

Medium-dose sufentanil group

Experimental group

Description:

The concentration of sufentanil is set to medium-dose concentration for the low-dose group

Treatment:

Drug: Sufentanil injection

High dose sufentanil group

Experimental group

Description:

The concentration of sufentanil is set to high concentration for the low-dose group

Treatment:

Drug: Sufentanil injection

Blank control group

Experimental group

Description:

No analgesics were given

Treatment:

Drug: Placebo