Low Dose Dexmedetomidine Versus Normal Saline in Multiple Fracture Ribs

NCT04928300 | Recruiting Phase 3 DMC

• 1 other identifier: 17300614
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rib Fractures

Outcome Measures

Primary Outcomes (1)

• 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. .

  5 days

Secondary Outcomes (1)

• Visual analogue scale for pain

  48 hours

Other Outcomes (1)

• Neutrophil/lymphocyte ratio (NLR)

  3 days

Study Arms (2)

Group D

EXPERIMENTAL

Dexmedetomidine infusion IV for 5 days.

Drug: Dexmedetomidine

Group C

PLACEBO COMPARATOR

The same dose and duration of normal saline will be given.

Other: 0.9% saline

Interventions

Dexmedetomidine DRUG

low dose dexmedetomidine infusion 0.2 µ/kg/hour IV for 5 days.

Also known as: Precedex

Group D

0.9% saline OTHER

the same dose and duration of normal saline will be given for 5 days.

Also known as: Normal saline

Group C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (age 18-65 years) of American Society of Anaesthesiologists (ASA) physical status I-II
• Traumatic multiple fracture ribs 3 ribs or more, who will be subjected to thorough assessments including chest 3D-CT
• Undergoing conservative treatment (chest strappings)
• Intractable pain with visual analogue scale (VAS) over 6 after traditional therapies
• Glasgow Coma Scale (GCS) ≥ 13.

You may not qualify if:

• Multiple traumas to body parts other than chest with an abbreviated injury scale over 3
• Serious head trauma with a Glasgow coma scale lower than 13
• Mechanically ventilated patients
• Massive hemothorax
• Injury to the trachea or bronchus with requirement for immediate surgery
• Dementia
• Use of corticosteroids during ICU stay
• Sepsis
• Continued use of neuromuscular blocking agents and aminoglycosides antibiotic use as they are known risk factors for ICU-acquired weakness and any known hypersensitivity
• Contraindication to the study drugs.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university hospital

Asyut, Assuit, Assuit universi, Egypt

RECRUITING

Related Publications (1)

• Bossolasco M, Bernardi E, Fenoglio LM. Continuous serratus plane block in a patient with multiple rib fractures. J Clin Anesth. 2017 May;38:85-86. doi: 10.1016/j.jclinane.2016.12.015. Epub 2017 Jan 30. No abstract available.

  PMID: 28372691 RESULT

MeSH Terms

Conditions

Rib Fractures

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Thoracic Injuries

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Omar Soliman, MD

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Omar Soliman, MD

CONTACT

01101266040; omarmakram347@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia and ICU

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: June 16, 2021
• Study Start: June 12, 2021
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 25, 2027
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

EG (1)