Low Dose Dexmedetomidine Versus Normal Saline in Multiple Fracture Ribs

Assiut University

Status and phase: Enrolling; Phase 3

Conditions: Rib Fractures

Treatments: Drug: Dexmedetomidine; Other: 0.9% saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04928300

17300614

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Group D

Experimental group

Description:

Dexmedetomidine infusion IV for 5 days.

Treatment:

Drug: Dexmedetomidine

Group C

Placebo Comparator group

Description:

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

Treatment:

Other: 0.9% saline