Low Dose Dexmedetomidine Versus Ketamine in Multiple Fracture Ribs

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

Tracking Information

• First Submitted Date: June 10, 2021
• First Posted Date: June 16, 2021
• Last Update Posted Date: March 29, 2022
• Actual Study Start Date: June 12, 2021
• Estimated Primary Completion Date: December 20, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: 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: Low Dose Dexmedetomidine Versus Ketamine in Multiple Fracture Ribs
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Care Provider); Primary Purpose: Treatment
• Condition: Rib Fractures

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 10, 2021): 90
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 25, 2023
• Estimated Primary Completion Date: December 20, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Omar Soliman, MD; 01101266040; omarmakram347@yahoo.com

• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT04928300
• Other Study ID Numbers: 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

• Plan to Share IPD: Undecided

• Current Responsible Party: Omar Makram Soliman, Assiut University
• Original Responsible Party: Same as current
• Current Study Sponsor: Assiut University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Omar Soliman, MD; Assiut University

• PRS Account: Assiut University
• Verification Date: March 2022