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NCT Number: NCT05951387

Dexmedetomidine Versus Dexmedetomidine with Ketamine in Mechanically Ventilated ARDS Patients

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.

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Key information

Conditions

Haemodynamic Instability

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Benha university

Banhā, Qalyubia Governorate, 13511, Egypt

About this study

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:

  • Thorough history taking and clinical examination
  • Calculation of acute physiology and chronic health evaluation (APACHE) score at time of ICU admission
  • Sedation score calculation using the Richmond Agitation-Sedation Scale (RASS)
  • ECG, blood pressure monitoring
  • Measurement of plasma C-reactive protein (CRP) level before and after initiation of sedation.
  • Measurement of oxygenation status (Pao2/Fio2) before and at 24, 48, 72, and 120 h after the administration of the sedatives
  • Any adverse effects related to sedation or intubation will be recoded

All data will be tabulated and statistically analyzed

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dexmedetomidine plus ketamine

Drug

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

Dexmedetomidine

Drug

starting intravenous infusion with dexmedetomidine starting at dose 0.5ug/kg//hr and titrate the dose to achieve full sedation

Other names: Group B

Primary outcomes

  1. oxygenation parameter

    Time frame: 24-27 hours

    change of PaO2/FiO2

  2. positive end expiratory pressure (PEEP)

    Time frame: 24-27 hours

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

Secondary outcomes

  1. serum level of C-reactive protein (CRP)

    Time frame: 24-72 hours

    change of serum level of CRP (mg/dl)

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

Comparative Study of Hemodynamic Changes and Sedation Effect of Dexmedetomidine Versus Dexmedetomidine with Ketamine in Mechanically Ventilated ARDS Patients, Randomized Clinical Trial

Acronym: ARDS

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 19, 2023
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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