Myocardial InjurySipwlefsmdfsNCT06808841
Sufentanil in Patients With Lower Extremity Fracture Surgery Myocardial Damage Function Study
A study testing Sufentanil injection in people with Myocardial Injury, run by Second Hospital of Shanxi Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Myocardial Injury
- What is being tested?
- Sufentanil injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 5 Feb 2025to 10 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
About this study
Official title: Sufentanil is Paired Via the BMP6/SMAD Pathway Cardiac Injury in Lower Extremity Fracture Surgery Function Study
- To analyze the association of different doses of opioids on myocardial injury/protection through BMP-6/SMAD pathway.
- To observe the effect of different doses of opioids on the expression of BMP-6 in bone marrow.
- To investigate the relationship between different doses of opioids and BMP-6 and perioperative cardiovascular adverse events in patients with lower extremity fracture surgery.
Read the 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.
- Conditions
- Myocardial Injury
- Being tested
- Sufentanil injection, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sufentanil injectionDrug
Also called Sufentanil dose
Different concentrations of sufentanil were administered to three different subgroups of patients in the same way
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Low dose sufentanil group | Experimental | The concentration of sufentanil is set to concentration for the low-dose group Receives: Drug: Sufentanil injection |
| Medium-dose sufentanil group | Experimental | The concentration of sufentanil is set to medium-dose concentration for the low-dose group Receives: Drug: Sufentanil injection |
| High dose sufentanil group | Experimental | The concentration of sufentanil is set to high concentration for the low-dose group Receives: Drug: Sufentanil injection |
| Blank control group | Experimental | No analgesics were given Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum BMP6
Dose measurement of BMP6 in serum
Measured: 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
Measured: Immediate postoperative measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start5 Feb 2025 (estimated)
- Primary completion10 May 2025 (estimated)
- Study completion10 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Hospital of Shanxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zheng Guo, Second Hospital of Shanxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808841
- Sponsor's protocol ID
- Gz20250110
- Acronym
- Sipwlefsmdfs
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2025
- Last updated
- 5 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sufentanil is Paired Via the BMP6/SMAD Pathway Cardiac Injury in Lower Extremity Fracture Surgery Function Study
- ClinicalTrials.gov ID
- NCT06808841
- Acronym / sponsor ID
- Sipwlefsmdfs / Gz20250110
- Conditions
- Myocardial Injury
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Second Hospital of Shanxi Medical UniversityUniversity, hospital or other
- Study start
- 5 Feb 2025 (estimated)
- Primary completion
- 10 May 2025 (estimated)
- Study completion
- 10 May 2025 (estimated)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To analyze the association of different doses of opioids on myocardial injury/protection through BMP-6/SMAD pathway.
- To observe the effect of different doses of opioids on the expression of BMP-6 in bone marrow.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low dose sufentanil group | Experimental | Drug: Sufentanil injectionThe concentration of sufentanil is set to concentration for the low-dose group |
| Medium-dose sufentanil group | Experimental | Drug: Sufentanil injectionThe concentration of sufentanil is set to medium-dose concentration for the low-dose group |
| High dose sufentanil group | Experimental | Drug: Sufentanil injectionThe concentration of sufentanil is set to high concentration for the low-dose group |
| Blank control group | Experimental | Drug: PlaceboNo analgesics were given |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sufentanil injectionAlso: Sufentanil doseDifferent concentrations of sufentanil were administered to three different subgroups of patients in the same way | Drug | High dose sufentanil group, Low dose sufentanil group, Medium-dose sufentanil group |
| PlaceboPlacebo | Drug | Blank control group |
Primary outcome
Serum BMP6
Time frame: Immediate postoperative measurement
Dose measurement of BMP6 in serum
1 secondary outcome
one marrow tissue BMP6
Time frame: Immediate postoperative measurement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sufentanil injection in people with Myocardial Injury, run by Second Hospital of Shanxi Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jvan Wu, Docter (15235361727, 13513520761@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum BMP6 (time frame: Immediate postoperative measurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.