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

ConditionMyocardial Injury
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSecond Hospital of Shanxi Medical University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sufentanil injection

    Drug

    Different concentrations of sufentanil were administered to three different subgroups of patients in the same way

  • Placebo

    Drug

    Placebo

Treatment groups

160 Participants
are divided into 4 treatment groups
Group A: Low dose sufentanil groupExperimental treatment 1 intervention
Group B: Medium-dose sufentanil groupExperimental treatment 1 intervention
Group C: High dose sufentanil groupExperimental treatment 1 intervention
Group D: Blank control groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Serum BMP6

Dose measurement of BMP6 in serum

Time frame
Immediate postoperative measurement

Secondary outcomes

1

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

Time frame
Immediate postoperative measurement

Other outcomes

1

Perioperative cardiac adverse events

To observe the effects of opioids and BMP6 on perioperative cardiovascular adverse events (ACVE) in patients with lower extremity fractures

Time frame
Immediate postoperative measurement

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Hospital of Shanxi Medical University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: