Dexmedetomidine Versus Dexmedetomidine With Ketamine in Mechanically Ventilated ARDS Patients

Haemodynamic Instability Clinical Trial

— ARDS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05951387
• Other study ID #: RC 37-5-2023
• Status: Recruiting
• Phase: Phase 4
• Start date: June 1, 2023
• Est. completion date: June 2024

Study information

• Verified date: July 2023
• Source: Benha University
• Contact: marwa Elnaggar, MD
• Phone: 02 01000629891
• Email: marwa_141282[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Haemodynamic Instability

Intervention

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

Locations

Country	Name	City	State
Egypt	Benha university	Banha	Qalubia

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oxygenation parameter	change of PaO2/FiO2	24-27 hours
Primary	positive end expiratory pressure (PEEP)	change of PEEP parameter that need to maintain oxygen saturation above 88%	24-27 hours
Secondary	serum level of C-reactive protein (CRP)	change of serum level of CRP (mg/dl)	24-72 hours