Actively Recruiting

Phase 3
Age: 18Years - 65Years
All Genders
ID04928300

Diaphragmatic Function, Pain Quality & Anti-inflammatory Properties Comparing Low Dose Dexmedetomidine Versus Normal Saline in Adults With Multiple Rib Fractures Receiving Conservative Treatment

Led by Assiut University · Updated on 2026-01-02

60

Participants Needed

1

Research Sites

3 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to compare the effects of low dose dexmedetomidine infusion with normal saline on diaphragmatic function, pain quality, and anti-inflammatory properties in patients who have multiple fractured ribs and are receiving conservative treatment. The study focuses on adults aged 18 to 65 years with three or more rib fractures caused by trauma. Participants will be randomly assigned to one of two groups: one group will receive a low dose dexmedetomidine infusion of 0.2 micrograms per kilogram per hour intravenously for 5 days during their ICU stay, while the other group will receive a matching dose and duration of normal saline. Before starting the intervention, a thoracic epidural will be inserted. The treatment period lasts for 5 days. During the study, participants will undergo assessments including ultrasonographic evaluation of diaphragm function over 5 days and pain measurement using a visual analogue scale during the first 48 hours. Researchers will monitor diaphragmatic performance, pain levels, and inflammation. The study involves close monitoring during ICU admission and collects data to evaluate the treatments’ impact on respiratory muscle function and pain control.

CONDITIONS

Brief Title

Low Dose Dexmedetomidine Versus Normal Saline in Multiple Fracture Ribs

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 65 years with American Society of Anaesthesiologists (ASA) physical status I-II
  • Traumatic multiple rib fractures involving 3 or more ribs confirmed by chest 3D-CT
  • Receiving conservative treatment such as chest strappings
  • Experiencing intractable pain with a visual analogue scale (VAS) score over 6 despite traditional therapies
  • Glasgow Coma Scale (GCS) score of 13 or higher
Not Eligible

You will not qualify if you...

  • Multiple injuries to other body parts with an abbreviated injury scale over 3
  • Serious head trauma with Glasgow Coma Scale below 13
  • Patients who are mechanically ventilated
  • Presence of massive hemothorax
  • Injury to trachea or bronchus requiring immediate surgery
  • Diagnosis of dementia
  • Use of corticosteroids during ICU stay
  • Sepsis
  • Ongoing use of neuromuscular blocking agents or aminoglycoside antibiotics
  • Known hypersensitivity or contraindication to study drugs

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Treatment

Duration - 5 days

Participants receive either low dose dexmedetomidine infusion or normal saline infusion intravenously for 5 days during ICU admission.

Daily visits during ICU stay for 5 days

Trial Site Locations

Total: 1 location

1

Assiut university hospital

Asyut, Assuit, Egypt, Assuit universi

Actively Recruiting

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Research Team

O

Omar Soliman, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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