Low Dose Dexmedetomidine Versus Normal Saline in Multiple Fracture Ribs

Phase 3RecruitingNCT04928300

Assiut University60 enrolled

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Rib Fractures

Interventions

DexmedetomidineDRUG

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

0.9% salineOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Assiut university hospital

Asyut, Assuit, Egypt

RECRUITING

Outcomes

Primary Outcomes

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. .

Time frame: 5 days

Secondary Outcomes

Visual analogue scale for pain

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.

Time frame: 48 hours

Central Contacts

Omar Soliman, MD

CONTACT

01101266040 omarmakram347@yahoo.com

Data from ClinicalTrials.gov

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