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

Sufentanil is Paired Via the BMP6/SMAD Pathway Cardiac Injury in Lower Extremity Fracture Surgery Function Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Myocardial Injury
• Intervention / Treatment: Drug: Placebo; Drug: Sufentanil injection

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 Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jvan Wu, Docter; Phone Number: 15235361727; Email: 13513520761@163.com

Study Locations

• China
  • Shanxi
    • Taiyuan, Shanxi, China, 030001
      • Second Hospital of Shanxi Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low dose sufentanil group; The concentration of sufentanil is set to concentration for the low-dose group	Drug: Sufentanil injection; Different concentrations of sufentanil were administered to three different subgroups of patients in the same way; Other Names: Sufentanil dose
Experimental: Medium-dose sufentanil group; The concentration of sufentanil is set to medium-dose concentration for the low-dose group	Drug: Sufentanil injection; Different concentrations of sufentanil were administered to three different subgroups of patients in the same way; Other Names: Sufentanil dose
Experimental: High dose sufentanil group; The concentration of sufentanil is set to high concentration for the low-dose group	Drug: Sufentanil injection; Different concentrations of sufentanil were administered to three different subgroups of patients in the same way; Other Names: Sufentanil dose
Experimental: Blank control group; No analgesics were given	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum BMP6	Dose measurement of BMP6 in serum	Immediate postoperative measurement

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative cardiac adverse events	To observe the effects of opioids and BMP6 on perioperative cardiovascular adverse events (ACVE) in patients with lower extremity fractures	Immediate postoperative measurement

Collaborators and Investigators

• Sponsor: Second Hospital of Shanxi Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): February 5, 2025
• Primary Completion (Estimated): May 10, 2025
• Study Completion (Estimated): May 10, 2025

Study Registration Dates

• First Submitted: January 10, 2025
• First Submitted That Met QC Criteria: February 4, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Intravenous; Anesthetics, General; Dsuvia; Sufentanil
• Other Study ID Numbers: Gz20250110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No