Nebulized Dexmedetomidine Combined With Ketamine Versus Nebulized Dexmedetomidine for Cleft Palate
NCT ID: NCT05821972
Last Updated: 2025-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
60 participants
INTERVENTIONAL
2024-04-10
2025-10-30
Brief Summary
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Detailed Description
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The pre-operative period is quite distressing for children due to parental separation, application of face mask for induction of anaesthesia, fear of needles and unfamiliar faces. Pre-operative Anxiety is associated with adverse outcomes via elevation of stress markers, promoting fluctuations in hemodynamic, and negatively impacting postoperative recovery. There is a growing interest in the use of dexmedetomidine, a highly selective alpha-2 adrenergic agonist, for paediatric premedication. Ketamine may attenuate dexmedetomidine-induced bradycardia and hypotension and accelerate the onset of sedation with no respiratory depression.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Nebulized dexmedetomidine and ketamine
Pre-operative nebulization of dexmedetomidine and ketamine
Nebulization of dexmedetomidine and ketamine
Pre-operative nebulization of dexmedetomidine and ketamine
Nebulized dexmedetomidine
Pre-operative nebulization of dexmedetomidine
Nebulization of dexmedetomidine
Pre-operative nebulization of dexmedetomidine
Interventions
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Nebulization of dexmedetomidine and ketamine
Pre-operative nebulization of dexmedetomidine and ketamine
Nebulization of dexmedetomidine
Pre-operative nebulization of dexmedetomidine
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Allergy to the study drugs
* Suspected difficult airway
* Patients with endocrine, renal, hepatic, and cardiac pathology
* Psychiatric diseases
* Asthmatic patients.
12 Months
48 Months
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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FATMA NABIL AHMED MOHAMED
Clinical Supervisor
Locations
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Assiut University
Asyut, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Samar A Abdellah
Role: backup
Other Identifiers
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Dexmedetomidine Ketamine
Identifier Type: -
Identifier Source: org_study_id
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