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Not yet recruiting NCT06808841

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

No phase Interventional Myocardial Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sufentanil injection, Placebo.
Who it may be relevant to
Registry conditions: Myocardial Injury. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug Sufentanil injection
    Different concentrations of sufentanil were administered to three different subgroups of patients in the same way
  • Drug Placebo
    Placebo

Primary outcome measures

  • Serum BMP6 [Time frame: Immediate postoperative measurement]
Secondary outcome measures (1)
  • one marrow tissue BMP6 [Time frame: Immediate postoperative measurement]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Second Hospital of Shanxi Medical University — Taiyuan

Identifiers

NCT: NCT06808841 · Gz20250110

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗