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Low Dose Dexmedetomidine Versus Ketamine in Multiple Fracture Ribs

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ClinicalTrials.gov Identifier: NCT04928300
Recruitment Status : Recruiting
First Posted : June 16, 2021
Last Update Posted : March 29, 2022
Sponsor:
Information provided by (Responsible Party):
Omar Makram Soliman, Assiut University

Tracking Information
First Submitted Date  ICMJE June 10, 2021
First Posted Date  ICMJE June 16, 2021
Last Update Posted Date March 29, 2022
Actual Study Start Date  ICMJE June 12, 2021
Estimated Primary Completion Date December 20, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2021)
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. .
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2021)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 10, 2021)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Low Dose Dexmedetomidine Versus Ketamine in Multiple Fracture Ribs
Official Title  ICMJE Diaphragmatic Function, Pain Quality & Anti-inflammatory Properties: A Low Dose Dexmedetomidine Versus Ketamine in Patients With Multiple Fracture Ribs Needing Conservative Treatment
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Rib Fractures
Intervention  ICMJE
  • Drug: Dexmedetomidine
    low dose dexmedetomidine infusion 0.2 µ/kg/hour IV for 5 days.
    Other Name: Precedex
  • Drug: Ketamine
    low dose ketamine infusion 2.5 µ/kg/min for 5 days.
    Other Name: ketalar
  • Other: 0.9% saline
    the same dose and duration of normal saline will be given for 5 days.
    Other Name: Normal saline
Study Arms  ICMJE
  • Experimental: Group D
    Dexmedetomidine infusion IV for 5 days.
    Intervention: Drug: Dexmedetomidine
  • Experimental: Group K
    Ketamine infusion 2.5 µ/kg/min for 5 days.
    Intervention: Drug: Ketamine
  • Placebo Comparator: Group C
    The same dose and duration of normal saline will be given.
    Intervention: Other: 0.9% saline
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 10, 2021)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 25, 2023
Estimated Primary Completion Date December 20, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Omar Soliman, MD 01101266040 omarmakram347@yahoo.com
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04928300
Other Study ID Numbers  ICMJE 17300614
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Omar Makram Soliman, Assiut University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Assiut University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Omar Soliman, MD Assiut University
PRS Account Assiut University
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP