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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06808841
Acronym
Sipwlefsmdfs
Enrollment
160
Registered
2025-02-05
Start date
2025-02-05
Completion date
2025-05-10
Last updated
2025-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Injury

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.

Interventions

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

DRUGPlacebo

Placebo

Sponsors

Second Hospital of Shanxi Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Serum BMP6Immediate postoperative measurementDose measurement of BMP6 in serum

Secondary

MeasureTime frameDescription
one marrow tissue BMP6Immediate postoperative measurementTo observe the effect of different doses of opioids on the expression of BMP-6 in bone marrow tissue of fracture end

Other

MeasureTime frameDescription
Perioperative cardiac adverse eventsImmediate postoperative measurementTo observe the effects of opioids and BMP6 on perioperative cardiovascular adverse events (ACVE) in patients with lower extremity fractures

Countries

China

Contacts

Primary ContactJvan Wu, Docter
13513520761@163.com15235361727

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026