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

NCT ID: NCT06808841

Last Updated: 2025-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-05

Study Completion Date

2025-05-10

Brief Summary

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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

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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

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Myocardial Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Low dose sufentanil group

The concentration of sufentanil is set to concentration for the low-dose group

Group Type EXPERIMENTAL

Sufentanil injection

Intervention Type DRUG

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

Medium-dose sufentanil group

The concentration of sufentanil is set to medium-dose concentration for the low-dose group

Group Type EXPERIMENTAL

Sufentanil injection

Intervention Type DRUG

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

High dose sufentanil group

The concentration of sufentanil is set to high concentration for the low-dose group

Group Type EXPERIMENTAL

Sufentanil injection

Intervention Type DRUG

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

Blank control group

No analgesics were given

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Placebo

Interventions

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Sufentanil injection

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

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Other Intervention Names

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Sufentanil dose

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Second Hospital of Shanxi Medical University

OTHER

Sponsor Role lead

Responsible Party

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Zheng Guo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Site Status

Countries

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China

Central Contacts

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Jvan Wu, Docter

Role: CONTACT

15235361727

Other Identifiers

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Gz20250110

Identifier Type: -

Identifier Source: org_study_id

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