An interventional study of 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 CPAP Ventilation, Sedation and Hemodynamics Instability, sponsored by Ain Shams University. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Ain Shams University · Not applicable, Interventional, and Other
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.
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.
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
Ain Shams University is the lead sponsor of 1,930 studies on the registry; 433 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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).(
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).(
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.
Time frame: 48 hours
• 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.
Time frame: 48 hours
• Oxygen saturation
Peripheral oxygen saturation (SpO₂, %) will be recorded throughout the 48-hour assessment period.
Time frame: 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.
Time frame: 48 hour
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