Low Dose Dexmedetomidine Versus Normal Saline in Multiple Fracture Ribs
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dexmedetomidine, 0.9% saline.
- Who it may be relevant to
- Registry conditions: Rib Fractures. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Diaphragmatic Function, Pain Quality & Anti-inflammatory Properties: A Low Dose Dexmedetomidine Versus Ketamine in Patients With Multiple Fracture Ribs Needing Conservative Treatment
Overview
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.
Detailed description
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.
Interventions
- Drug Dexmedetomidine
low dose dexmedetomidine infusion 0.2 µ/kg/hour IV for 5 days. - Other 0.9% saline
the same dose and duration of normal saline will be given for 5 days.
Primary outcome measures
- Ultrasonographic diaphragm function [Time frame: 5 days]
Secondary outcome measures (1)
- Visual analogue scale for pain [Time frame: 48 hours]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Assiut university hospital — Asyut
Publications
- 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
Identifiers
NCT: NCT04928300 · 17300614