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NCT Number: NCT06808841

Sufentanil in Patients With Lower Extremity Fracture Surgery Myocardial Damage 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.

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Key information

Conditions

Myocardial Injury

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sufentanil injection

Drug

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

Other names: Sufentanil dose

Placebo

Drug

Placebo

Primary outcomes

  1. Serum BMP6

    Time frame: Immediate postoperative measurement

    Dose measurement of BMP6 in serum

Secondary outcomes

  1. one marrow tissue BMP6

    Time frame: 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

Other outcomes

  1. Perioperative cardiac adverse events

    Time frame: Immediate postoperative measurement

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jvan Wu, Docter

CONTACT

[email protected]

15235361727

Sponsors and collaborators

Lead sponsor

Second Hospital of Shanxi Medical University

Other

Registry information

Official study title

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

Acronym: Sipwlefsmdfs

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 5, 2025
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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