Diaphragmatic Function, Pain Quality & Anti-inflammatory Properties: A Low Dose Dexmedetomidine Versus Ketamine in Patients With Multiple Fracture Ribs Needing Conservative Treatment
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Assiut University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Ultrasonographic diaphragm function
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Use of corticosteroids during ICU stay
- •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.
Arms & Interventions
Group D
Dexmedetomidine infusion IV for 5 days.
Intervention: Dexmedetomidine (Drug)
Group C
The same dose and duration of normal saline will be given.
Intervention: 0.9% saline (Other)
Outcomes
Primary Outcomes
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
- Visual analogue scale for pain(48 hours)
Investigators
Omar Makram Soliman
Lecturer of anesthesia and ICU
Assiut University