A Phase 3 interventional study of Dexmedetomidine and 0.9% saline in Rib Fractures, sponsored by Assiut University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-01-02.
Sponsored by Assiut University · Phase 3, Interventional, and Treatment
In our study, we assess the diaphragmatic function, pain quality and anti-inflammatory properties between low dose infusion of dexmedetomidine normal saline in patients with multiple fracture ribs on conservative treatment.
A written informed consent from patients or thier legal guardians, Patients will be assigned randomly to two groups (30 subjects each) with traumatic multiple fracture ribs 3 ribs or more. After thoracic epidural is inserted, the drug study intervention will be started and run for 5 days during ICU admission. In (Group D) low dose dexmedetomidine infusion 0.2 µ/kg/hour IV for 5 days. In (Group C) the same dose and duration of normal saline will be given.
131 studies on the registry are indexed under Rib Fractures; 27 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 99 interventional studies indexed under Rib Fractures.
Browse Rib Fractures studies →Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Dexmedetomidine infusion IV for 5 days.
Drug: Dexmedetomidine
The same dose and duration of normal saline will be given.
Other: 0.9% saline
low dose dexmedetomidine infusion 0.2 µ/kg/hour IV for 5 days.
Also known as: Precedex
the same dose and duration of normal saline will be given for 5 days.
Also known as: Normal saline
Ultrasonographic diaphragm function
Diaphragmatic excursion and thickness will be assessed by ultasound for 5 days with diaphragmatic dysfunction (DD) is diagnosed if diaphragmatic excursion is \<10 mm and diaphragmatic thickness is \<2 mm. .
Time frame: 5 days
Visual analogue scale for pain
Severity of pain will be assessed and scored by 10-point visual analogue scale (VAS). The patients will be instructed on how to use VAS for the assessment of the degree of pain (with 0 representing no pain and 10 cm representing the worst imaginable pain). According to the degree pain given by the patient, classification of pain severity will be done as follows: no pain = 0, mild pain \<3, moderate pain 4-6 and severe pain \>7. VAS will be recorded at zero time before drug intervention, 4 h, 6 h, 12 h, 24 h and 48 h after the start of the treatment in all groups by the anesthesia resident not involved in any other part of the study.
Time frame: 48 hours
Neutrophil/lymphocyte ratio (NLR)
From complete blood picture, neutrophil/lymphocyte ratio is measured to assess anti-inflammatory properties of the study drugs daily for 3 days.
Time frame: 3 days
Plan to share: Undecided
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Assiut University