CPAP VentilationCPAPNCT07888192
Dexametedomidine Ketamine Infusion Versus Dexametedomidine Propofol Infusion in Non-compliant Agitated Patients on Continuous Positive Airway Pressure (CPAP) Mask Ventilation in the Intensive Care Unit
A study testing Group DK will receive dexmedetomidine (0.2-1.4 μg/kg/hour) and ketamine (0.5 mg/kg/hr). and Group KP will receive dexmedetomidine (0.2-1.4 μg/kg/hour) and propofol (2-4 mg/kg/hr).( in people with CPAP Ventilation and Sedation, run by Ain Shams University.
Trial summary
Continuous positive airway pressure (CPAP) is a type of positive airway pressure, where the air flow is introduced into the airways to maintain a continuous pressure to constantly stent the airways open, in people who are breathing spontaneously. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- CPAP Ventilation, Sedation, Hemodynamics Instability
- What is being tested?
- Group DK will receive dexmedetomidine (0.2-1.4 μg/kg/hour) and ketamine (0.5 mg/kg/hr). and Group KP will receive dexmedetomidine (0.2-1.4 μg/kg/hour) and propofol (2-4 mg/kg/hr).(
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age from 18 Year to 60 year.
- Both gender
Who cannot join
- Hypersensitivity to drugs
- Any contraindication to CPAP.
- Refusal of patients
- Patients with disturbed conscious level GCS<8
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
shafei contact
About this study
Continuous positive airway pressure (CPAP) is a type of positive airway pressure, where the air flow is introduced into the airways to maintain a continuous pressure to constantly stent the airways open, in people who are breathing spontaneously.
The application of CPAP maintains positive end expiratory pressure (PEEP), can decrease atelectasis, increases the surface area of the alveolus, improves V/Q matching, and hence, improves oxygenation.
Read more
Analgesia and sedation are essential components of care for critically ill patients, helping to relieve pain and anxiety, facilitate invasive procedures, reduce physiological stress and oxygen demand, and improve patient-ventilator synchrony. However, sedation practices vary considerably due to differences in institutional protocols, clinician preferences, and patient characteristics. Both inadequate and excessive sedation can adversely affect outcomes: untreated pain and agitation increase the sympathetic stress response, while oversedation is associated with prolonged mechanical ventilation, longer intensive care unit (ICU) stays, and a higher incidence of delirium and coma.
Combinations of propofol, benzodiazepines and opioids are frequently used for sedation. Opioids are usually added in painful procedures because benzodiazepines and propofol do not have any analgesic effect. However, opioid administration can lead to excessive sedation and some side effects.
Propofol (non-opioid, non-barbiturate, short-acting anesthetic agent) is popular in sedation because of its rapid induction and recovery times. However, its side effects, particularly cardiopulmonary depression, apnea and hypoventilation, have attracted attention to the search for alternatives.
Ketamine can be an alternative to opioids because it provides good analgesia even at low doses, sparing the respiratory and cardiovascular adverse effects of opioids. Unfortunately, its side effects (increased salivation, nausea, nightmares, delirium, and excitation) do not make it favorable as a single agent.
The past few years have carried increased interest in dexmedetomidine (a selective alpha-2 receptor agonist) in both anesthesia and intensive care. This alpha-2 receptor agonist has been used as the drug of choice for sedation in pediatric patients because of its lack of respiratory depressive effects, adequate sedative and analgesic action, and favorable antiarrhythmic effects.
Furthermore, minimizing benzodiazepine use and preferentially using propofol or dexmedetomidine to achieve appropriate sedation levels are associated with improved clinical outcomes.
Read the detailed description
This prospective Non inferiority randomized clinical trial will be conducted on (100) patients stayed in icu unit of Ain Shams University Hospitals scheduled for CPAP ventilator support. The participants will be enrolled from acceptance of ethical committee till completion of cases after the approval of the Ethical Medical Committee and obtaining a written informed consent from them or guardians. Patients were randomly divided into 2 groups (50 each group) using a computer-generated random number table to either dexametedomidine-ketamine group (group DK), or dexametedomidine-propofol (group DP).
For all enrolled patients, full history, clinical examination and routine laboratory investigations will be done.
Group DK will receive dexmedetomidine (0.2-1.4 μg/kg/hour) and ketamine (0.5 mg/kg/hr). (7)(8) Group KP will receive dexmedetomidine (0.2-1.4 μg/kg/hour) and propofol (2-4 mg/kg/hr).(8)(9) Duration will be as long as the patient is in need for CPAP Depth of sedation Will be assessed using the Richmond sedation agitation score (RASS scores)[5], which range from -5 (unarousable) to +4 (combative). target RASS score Will be determined before starting study treatment and at daily sedation stops. Assessment of RASS score will be performed every 2 hours and prior to any dose of rescue therapy and study will determine the first 2 days of sedation.
The first primary efficacy end point will be the proportion of time in target sedation range (RASS score, 0 to -3) without use of rescue therapy of the total duration of study drug infusion.
Expected complications for ketamin are vivid dreams tachycardia and salivation , and for propofol may produce hemodynamic instability and propofol infusion syndrome ,and for dexmedetomidine may show hypotension and bradycardia refusing candidates will receive conventional sedation with opiates or with a single agent of the studied medications
- Conditions
- CPAP Ventilation, Sedation, Hemodynamics Instability
- Being tested
- Group DK will receive dexmedetomidine (0.2-1.4 μg/kg/hour) and ketamine (0.5 mg/kg/hr)., Group KP will receive dexmedetomidine (0.2-1.4 μg/kg/hour) and propofol (2-4 mg/kg/hr).(
- Keywords
- CPAP, intensive care unit, dexmedetomedine, ketamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group DK will receive dexmedetomidine (0.2-1.4 μg/kg/hour) and ketamine (0.5 mg/kg/hr).Other
Group DK will receive dexmedetomidine (0.2-1.4 μg/kg/hour) and ketamine (0.5 mg/kg/hr).
Group KP will receive dexmedetomidine (0.2-1.4 μg/kg/hour) and propofol (2-4 mg/kg/hr).(Other
Group KP will receive dexmedetomidine (0.2-1.4 μg/kg/hour) and propofol (2-4 mg/kg/hr).(
| Study group | Role | What they receive |
|---|---|---|
| Group DK | Active comparator | Group DK will receive dexmedetomidine (0.2-1.4 μg/kg/hour) and ketamine (0.5 mg/kg/hr). Receives: Other: Group DK will receive dexmedetomidine (0.2-1.4 μg/kg/hour) and ketamine (0.5 mg/kg/hr). |
| Group KP | Active comparator | Group KP will receive dexmedetomidine (0.2-1.4 μg/kg/hour) and propofol (2-4 mg/kg/hr) Receives: Other: Group KP will receive dexmedetomidine (0.2-1.4 μg/kg/hour) and propofol (2-4 mg/kg/hr).( |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of each type of sedation on the outcome of the CPAP as for more compliant patient and lesser side effects
The first primary efficacy end point will be the proportion of time in target sedation range (RASS score, 0 to -3) without use of rescue therapy of the total duration of study drug infusion.
Measured: 48 hours
Secondary outcomes (3)
• Sedation level and efficacy
The level and adequacy of sedation will be assessed using the Richmond Agitation-Sedation Scale (RASS). RASS scores will be recorded at predefined assessment time points during the 48-hour study period.
Measured: 48 hours
• Oxygen saturation
Peripheral oxygen saturation (SpO₂, %) will be recorded throughout the 48-hour assessment period.
Measured: 48 hour
• Adverse effects of dexmedetomidine
- Bradycardia: heart rate <60 beats/minute.
- Hypotension: a reduction in systolic blood pressure or mean arterial pressure of >20% from the patient's baseline value.
- Increased urine output: urine output >150 mL/hour.
Measured: 48 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CPAP VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The aim of this study is to compare the effect of Dexametedomidine ketamine infusion versus dexametedomidine propofol infusion in non-compliant agitated patients on continuous positive airway pressure (CPAP) mask ventilation in the intensive care unit Primary outcome The effect of each type of sedation on the outcome of the CPAP as for more compliant patient and lesser side effects Secondary outcome * Which sedation regimen has better sedation effects using the sedation score * Which sedation regimen has lesser side effects * Economic impact of each type of sedation on patients in ICU
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Gaber, Ain Shams University
- Investigators
- Amr Gaber, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07888192
- Sponsor's protocol ID
- agitated non compliant patient
- Acronym
- CPAP
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No