Dexmedetomidine Versus Dexmedetomidine with Ketamine in Mechanically Ventilated ARDS Patients (ARDS)

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

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.

Study Overview

• Status: Completed
• Conditions: Haemodynamic Instability
• Intervention / Treatment: Drug: dexmedetomidine plus ketamine; Drug: Dexmedetomidine

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Qalubia
    • Banhā, Qalubia, Egypt, 13511
      • Benha University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
positive end expiratory pressure (PEEP)	change of PEEP parameter that need to maintain oxygen saturation above 88%	24-27 hours
oxygenation parameter	change of PaO2/FiO2	24-27 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum level of C-reactive protein (CRP)	change of serum level of CRP (mg/dl)	24-72 hours

Collaborators and Investigators

• Sponsor: Benha University
• Investigators: Study Director: Marwa Elnaggar, MD, Benha University, Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): June 5, 2024

Study Registration Dates

• First Submitted: June 14, 2023
• First Submitted That Met QC Criteria: July 16, 2023
• First Posted (Actual): July 19, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: ARDS; ketamine; Dexmedetomidine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Hypnotics and Sedatives; Anesthetics, Intravenous; Anesthetics, General; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Excitatory Amino Acid Agents; Anesthetics, Dissociative; Excitatory Amino Acid Antagonists; Dexmedetomidine; Ketamine
• Other Study ID Numbers: RC 37-5-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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