NCT05951387

Dexmedetomidine Versus Dexmedetomidine with Ketamine in Mechanically Ventilated ARDS Patients

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Benha University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Haemodynamic Instability

Interventions

Type	Name	Description
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
DRUG	Dexmedetomidine	starting intravenous infusion with dexmedetomidine starting at dose 0.5ug/kg//hr and titrate the dose to achieve full sedation

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-06-01
• Completion: 2024-06-05
• First posted: 2023-07-19
• Last updated: 2025-02-11

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study