Low Dose Dexmedetomidine Versus Normal Saline in Multiple Fracture Ribs

NCT ID: NCT04928300

Last Updated: 2026-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-12

Study Completion Date

2027-07-25

Brief Summary

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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

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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.

Conditions

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Rib Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Group D

Dexmedetomidine infusion IV for 5 days.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

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

Group C

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

Group Type PLACEBO_COMPARATOR

0.9% saline

Intervention Type OTHER

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

Interventions

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Dexmedetomidine

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

Intervention Type DRUG

0.9% saline

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

Intervention Type OTHER

Other Intervention Names

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Precedex Normal saline

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Omar Makram Soliman

Lecturer of anesthesia and ICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Omar Soliman, MD

Role: STUDY_DIRECTOR

Assiut University

Locations

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Assiut university hospital

Asyut, Assuit, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Omar Soliman, MD

Role: CONTACT

01101266040

Facility Contacts

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Omar Soliman

Role: primary

01101266040

References

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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.

Reference Type RESULT
PMID: 28372691 (View on PubMed)

Other Identifiers

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17300614

Identifier Type: -

Identifier Source: org_study_id

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