Low Dose Dexmedetomidine Versus Ketamine in Multiple Fracture Ribs

April 11, 2023 updated by: Omar Makram Soliman, Assiut University

Diaphragmatic Function, Pain Quality & Anti-inflammatory Properties: A Low Dose Dexmedetomidine Versus Ketamine in Patients With Multiple Fracture Ribs Needing Conservative Treatment

In our study, we assess the diaphragmatic function, pain quality and anti-inflammatory properties between low dose infusion of dexmedetomidine and ketamine in patients with multiple fracture ribs on conservative treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A written informed consent from patients or thier legal guardians, Patients will be assigned randomly to three 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 K) low dose ketamine infusion 2.5 µ/kg/min for 5 days. In (Group C) the same dose and duration of normal saline will be given.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Assuit
      • Assiut, Assuit, Egypt, Assuit universi
        • Recruiting
        • Assiut University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group D
Dexmedetomidine infusion IV for 5 days.
Drug: Dexmedetomidine
low dose dexmedetomidine infusion 0.2 µ/kg/hour IV for 5 days.
Other Names:
  • Precedex
Experimental: Group K
Ketamine infusion 2.5 µ/kg/min for 5 days.
Drug: Ketamine
low dose ketamine infusion 2.5 µ/kg/min for 5 days.
Other Names:
  • ketalar
Placebo Comparator: Group C
The same dose and duration of normal saline will be given.
Other: 0.9% saline
the same dose and duration of normal saline will be given for 5 days.
Other Names:
  • Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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. .
5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue scale for pain
Time Frame: 48 hours
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.
48 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neutrophil/lymphocyte ratio (NLR)
Time Frame: 3 days
From complete blood picture, neutrophil/lymphocyte ratio is measured to assess anti-inflammatory properties of the study drugs daily for 3 days.
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Omar Soliman, MD, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2021

Primary Completion (Anticipated)

July 1, 2024

Study Completion (Anticipated)

July 25, 2024

Study Registration Dates

First Submitted

June 10, 2021

First Submitted That Met QC Criteria

June 10, 2021

First Posted (Actual)

June 16, 2021

Study Record Updates

Last Update Posted (Actual)

April 13, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17300614

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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