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Dexmedetomidine Versus Dexmedetomidine With Ketamine in Mechanically Ventilated ARDS Patients

Sponsor
Benha University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05951387
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this clinical trial study is to compare dexmedetomidine versus the combination of dexmedetomidine with ketamine in hemodynamic changes and sedative effects in ARDS patients who are in need of mechanical ventilation. The main question[s] it aims to answer are:

  • [question 1]: Which dose that get the target in sedation, single and combined drugs?

  • [question 2]: In which drug group that hemodynamic did not affect Participants will be patients with ARDS that will be divided into two group the first ont will receive dexmedetomidine 0.5 µg/kg/h mixed with ketamine 0.5 mg/kg/h and the second one will receive dexmedetomidine at 0.5 µg/kg/h infusion only. In both the groups, studied drugs will be titrated to achieve target sedation.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

This study will include 60 patients with ARDS who will be admitted to the intensive care unit (ICU) and chest ICU of Banha university hospitals during the period between June 2023 and June 2024.

ARDS will be diagnosed based on the presence of new or worsening symptoms within one week of a known clinical insult; bilateral opacities on anteroposterior chest X-ray that are not due to effusions, nodules or lobar or lung collapse; and hypoxemia, defined as arterial oxygen tension/fraction of inspired oxygen (Pao2/FiO2) < 300 mm Hg and a minimum positive end-expiratory pressure ≥ 5 cm H2O, that is not explained by heart failure or fluid overload.

Patients were divided randomly into two groups. Group A (n = 30); received with starting dose of dexmedetomidine 0.5 µg/kg/h mixed with ketamine 0.5 mg/kg/h and Group B (n = 30); received dexmedetomidine at 0.5 µg/kg/h infusion only. In both the groups, studied drugs will be titrated to achieve target sedation.

All patients will be subjected to the following:

  1. Thorough history taking and clinical examination

  2. Calculation of acute physiology and chronic health evaluation (APACHE) score at time of ICU admission

  3. Sedation score calculation using the Richmond Agitation-Sedation Scale (RASS)

  4. ECG, blood pressure monitoring

  5. Measurement of plasma C-reactive protein (CRP) level before and after initiation of sedation.

  6. Measurement of oxygenation status (Pao2/Fio2) before and at 24, 48, 72, and 120 h after the administration of the sedatives

  7. Any adverse effects related to sedation or intubation will be recoded

All data will be tabulated and statistically analyzed

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Comparative Study of Hemodynamic Changes and Sedation Effect of Dexmedetomidine Versus Dexmedetomidine With Ketamine in Mechanically Ventilated ARDS Patients, Randomized Clinical Trial
Actual Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: dexmedetomidine plus ketamine

starting intravenous infusion dose of dexmedetomidine 0.5 µg/kg/h mixed with ketamine 0.5 mg/kg/h to 30 mechanically ventilated ARDS patient

Drug: dexmedetomidine plus ketamine
titrating the dose of dexmedetomidine mixed with ketamine (staring dose 0.5ug/kg/hr, 0.5mg/kg/hr respectively)to achieve full sedation
Other Names:
  • Group A

    		•
    Active Comparator: high dose dexmedetomidine

    dexmedetomidine at 0.5 µg/kg/h intravenous infusion only to be titrated to achieve full sedation to 30 mechanically ventilated ARDS patient

    Drug: Dexmedetomidine
    starting intravenous infusion with dexmedetomidine starting at dose 0.5ug/kg//hr and titrate the dose to achieve full sedation
    Other Names:
  • Group B

    		•

    Outcome Measures

    Primary Outcome Measures

    1. oxygenation parameter [24-27 hours]

      improvement of PaO2/FiO2

    2. positive end expiratory pressure (PEEP) [24-27 hours]

      change of PEEP parameter that need to maintain oxygen saturation above 88%

    Secondary Outcome Measures

    1. serum level of C-reactive protein (CRP) [24-72 hours]

      improvement of serum level of CRP (mg/dl)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • patients with ARDS with the following:

    • Those whose duration of endotracheal intubation was > 120 h

    • those whose ages were 18- 70 years old

    • those with acute physiology and chronic health evaluation (APACHE) II scores > 12 points.

    Exclusion Criteria:

    • patients with a history of allergy to ketamine or dexmedetomidine

    • Pregnant women,

    • patients in the early stage of recovery,

    • patients with unstable hemodynamics, bradycardia, sinus arrest, or other cardiac arrhythmias

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Benha university Banhā Qalubia Egypt 13511

    Sponsors and Collaborators

    • Benha University

    Investigators

    • Study Director: Marwa Elnaggar, MD, Benha University, Faculty of medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marwa Elsayed Elnaggar, Assistant professor of chest diseases, Benha University
    ClinicalTrials.gov Identifier:
    NCT05951387
    Other Study ID Numbers:
    • RC 37-5-2023
    First Posted:
    Jul 19, 2023
    Last Update Posted:
    Jul 19, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Marwa Elsayed Elnaggar, Assistant professor of chest diseases, Benha University
    ARDS
    Dexmedetomidine
    ketamine
    Additional relevant MeSH terms:
    Dexmedetomidine
    Ketamine

    Study Results

    No Results Posted as of Jul 19, 2023