Dexmedetomidine Versus Dexmedetomidine with Ketamine in Mechanically Ventilated ARDS Patients

NCT ID: NCT05951387

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-06-05

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

dexmedetomidine plus ketamine

Intervention Type: DRUG

titrating the dose of dexmedetomidine mixed with ketamine (staring dose 0.5ug/kg/hr, 0.5mg/kg/hr respectively)to achieve full sedation

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

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Dexmedetomidine

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

Intervention Type: DRUG

Other Intervention Names

Group A; Group B

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

Marwa Elsayed Elnaggar

Assistant professor of chest diseases

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marwa Elnaggar, MD

Role: STUDY_DIRECTOR

Benha University, Faculty of medicine

Locations

Benha university

Banhā, Qalyubia Governorate, Egypt

Countries

Egypt

Other Identifiers

RC 37-5-2023

Identifier Type: -

Identifier Source: org_study_id