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

Not Applicable

Not yet recruiting

• Conditions: Myocardial Injury
• Interventions: Drug: Sufentanil injection; Drug: Placebo

• Registration Number: NCT06808841
• Lead Sponsor: Second Hospital of Shanxi Medical University

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-10
• Study First Submitted QC: 2025-02-04
• Last Update Submitted: 2025-02-04
• Study Start: 2025-02-05
• Study First Posted: 2025-02-05
• Last Update Posted: 2025-02-05
• Primary Completion: 2025-05-10
• Study Completion: 2025-05-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose sufentanil group	Sufentanil injection	The concentration of sufentanil is set to concentration for the low-dose group
Medium-dose sufentanil group	Sufentanil injection	The concentration of sufentanil is set to medium-dose concentration for the low-dose group
High dose sufentanil group	Sufentanil injection	The concentration of sufentanil is set to high concentration for the low-dose group
Blank control group	Placebo	No analgesics were given

Primary Outcome Measures

Name	Time	Method
Serum BMP6	Immediate postoperative measurement	Dose measurement of BMP6 in serum

Secondary Outcome Measures

Name	Time	Method
one marrow tissue BMP6	Immediate postoperative measurement	To observe the effect of different doses of opioids on the expression of BMP-6 in bone marrow tissue of fracture end

Trial Locations

Locations (1)

Second Hospital of Shanxi Medical University; 🇨🇳 Taiyuan, Shanxi, China