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NCT Number: NCT04928300

Low Dose Dexmedetomidine Versus Normal Saline in Multiple Fracture Ribs

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.

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Key information

Conditions

Rib Fractures Fractures, Bone Thoracic Injuries Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Assiut university hospital

Asyut, Assuit, Assuit universi, Egypt

Location status: Recruiting

Location contact

Omar Soliman

CONTACT

[email protected]

01101266040

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Dexmedetomidine

Drug

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

Other names: Precedex

0.9% saline

Other

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

Other names: Normal saline

Primary outcomes

  1. Ultrasonographic diaphragm function

    Time frame: 5 days

    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. .

Secondary outcomes

  1. Visual analogue scale for pain

    Time frame: 48 hours

    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.

Other outcomes

  1. Neutrophil/lymphocyte ratio (NLR)

    Time frame: 3 days

    From complete blood picture, neutrophil/lymphocyte ratio is measured to assess anti-inflammatory properties of the study drugs daily for 3 days.

Study contacts

Contact information is provided by the study sponsor or research team.

Omar Soliman, MD

CONTACT

[email protected]

01101266040

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Diaphragmatic Function, Pain Quality & Anti-inflammatory Properties: A Low Dose Dexmedetomidine Versus Ketamine in Patients With Multiple Fracture Ribs Needing Conservative Treatment

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jun 16, 2021
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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