Status:
NOT_YET_RECRUITING
Effects of Nasal Administration of Dexmedetomidine on Pre-anesthesia Sedation, Intraoperative Brain Electrical Activity, and Incidence of Agitation During Recovery in Children
Lead Sponsor:
Fuzhou Hua
Conditions:
Preoperative Anxiety
Emergence Agitation
Eligibility:
All Genders
2-6 years
Phase:
PHASE4
Brief Summary
Pre - operative anxiety and emergence agitation are common issues among pediatric patients, which have various influences on the recovery progress and prognosis of children. Nasal administration of de...
Eligibility Criteria
Inclusion
- 2≤ age ≤6 years old, gender is not limited;
- ASA anesthesia grade I \~ II; ③ For children who intend to undergo minor surgery under general anesthesia (including but not limited to minor surgery such as ENT surgery and hernia surgery), the operation duration is expected to be no more than 2 hours; ④ Family members agree to participate in the study and voluntarily sign informed consent;
Exclusion
- Respiratory tract infection occurs within 4 weeks before surgery;
- Potential or other contraindications to general anesthesia;
- There are nasal diseases, nasal bleeding, sinusitis, nasal polyps and other conditions that affect nasal absorption; ④ Heart, liver, kidney and other vital organ dysfunction or blood system diseases;
- Allergy or intolerance to dexmedetomidine or other α2-adrenergic receptor agonists;
- Patients with mental illness or neurological diseases;
- Unable to complete the test, the child's guardian refused to participate; ⑧ Have participated in other clinical trials or need to participate in other clinical trials during the study period; ⑨ Other reasons that the researchers consider inappropriate to participate in this study.
Key Trial Info
Start Date :
March 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
627 Patients enrolled
Trial Details
Trial ID
NCT06896721
Start Date
March 20 2025
End Date
March 31 2026
Last Update
March 26 2025
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