NCT06808841

Brief Summary

  1. 1.To analyze the association of different doses of opioids on myocardial injury/protection through BMP-6/SMAD pathway.
  2. 2.To observe the effect of different doses of opioids on the expression of BMP-6 in bone marrow.
  3. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2025

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 5, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

February 5, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2025

Completed
Last Updated

February 5, 2025

Status Verified

January 1, 2025

Enrollment Period

3 months

First QC Date

January 10, 2025

Last Update Submit

February 4, 2025

Conditions

Myocardial Injury

Outcome Measures

Primary Outcomes (1)

  • Serum BMP6

    Dose measurement of BMP6 in serum

    Immediate postoperative measurement

Secondary Outcomes (1)

  • one marrow tissue BMP6

    Immediate postoperative measurement

Other Outcomes (1)

  • Perioperative cardiac adverse events

    Immediate postoperative measurement

Study Arms (4)

Low dose sufentanil group

EXPERIMENTAL

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

Drug: Sufentanil injection

Medium-dose sufentanil group

EXPERIMENTAL

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

Drug: Sufentanil injection

High dose sufentanil group

EXPERIMENTAL

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

Drug: Sufentanil injection

Blank control group

EXPERIMENTAL

No analgesics were given

Drug: Placebo

Interventions

Sufentanil injectionDRUG

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

Also known as: Sufentanil dose
High dose sufentanil groupLow dose sufentanil groupMedium-dose sufentanil group
PlaceboDRUG

Placebo

Blank control group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

Location

MeSH Terms

Interventions

Sufentanil

Intervention Hierarchy (Ancestors)

FentanylPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Jvan Wu, Docter

CONTACT

1523536172713513520761@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 10, 2025

First Posted

February 5, 2025

Study Start

February 5, 2025

Primary Completion

May 10, 2025

Study Completion

May 10, 2025

Last Updated

February 5, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)