Dexmedetomidine Versus Dexmedetomidine with Ketamine in Mechanically Ventilated ARDS Patients

NCT05951387 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: RC 37-5-2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Haemodynamic Instability

Keywords

ARDS; Dexmedetomidine; ketamine

Outcome Measures

Primary Outcomes (2)

• oxygenation parameter

  change of PaO2/FiO2

  24-27 hours

• positive end expiratory pressure (PEEP)

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

  24-27 hours

Secondary Outcomes (1)

• serum level of C-reactive protein (CRP)

  24-72 hours

Study Arms (2)

dexmedetomidine plus ketamine

ACTIVE COMPARATOR

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

high dose dexmedetomidine

ACTIVE COMPARATOR

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

Interventions

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

Also known as: Group A

dexmedetomidine plus ketamine

Dexmedetomidine DRUG

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

Also known as: Group B

high dose dexmedetomidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha university

Banhā, Qalyubia Governorate, 13511, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine; Ketamine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Marwa Elnaggar, MD

  Benha University, Faculty of medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of chest diseases

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: July 19, 2023
• Study Start: June 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 5, 2024
• Last Updated: February 11, 2025

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)