NCT05821972 Nebulized Dexmedetomidine Combined With Ketamine Versus Nebulized Dexmedetomidine for Cleft Palate
| NCT ID | NCT05821972 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Assiut University |
| Condition | Sedation |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-04-10 |
| Primary Completion | 2025-10-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60 participants in total. It began in 2024-04-10 with a primary completion date of 2025-10-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To compare the efficacy of the pre-operative nebulization of a combination of dexmedetomidine and ketamine versus nebulization of dexmedetomidine alone for sedation and prevention of emergence delirium in children undergoing cleft palate repair surgeries.
Eligibility Criteria
Inclusion Criteria: * Patients with American Society of Anesthesiologists (ASA) physical status I \& II who will be scheduled for cleft palate repair surgeries Exclusion Criteria: * Parent refusal * Allergy to the study drugs * Suspected difficult airway * Patients with endocrine, renal, hepatic, and cardiac pathology * Psychiatric diseases * Asthmatic patients.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05821972 clinical trial?
This trial is open to participants of all sexes, aged 12 Months or older, up to 48 Months, studying Sedation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05821972 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05821972 currently recruiting?
Yes, NCT05821972 is actively recruiting participants. Contact the research team at fatmanabil2012@aun.edu.eg for enrollment information.
Where is the NCT05821972 trial being conducted?
This trial is being conducted at Asyut, Egypt.
Who is sponsoring the NCT05821972 clinical trial?
NCT05821972 is sponsored by Assiut University. The trial plans to enroll 60 participants.