Clinical Trial

Determination of ED50 and ED95 With Clinical Efficacy of Intranasal Dexmedetomidine Combined With Esketamine for Preoperative Sedation in Pediatric General Anesthesia

Recruiting Phase 4
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Summary
For pediatric patients undergoing general anesthesia, poor anesthesia induction compliance often has adverse effects on individual behavior in the early postoperative period. Dexmedetomidine can reduce the cardiovascular responses and postoperative mental adverse reactions caused by esketamine anesthesia induction \[6\]. This study aims to explore the ED50 and ED95 and clinical effects of the combination of dexmedetomidine and esketamine nasal drops for preoperative sedation in children of different ages undergoing general anesthesia, providing a theoretical basis for the combined use of dexmedetomidine and esketamine for preoperative sedation in children undergoing general anesthesia.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-02-27; most recent amendment 2025-11-24.
Status change: Not Yet Recruiting → Recruiting 2025-03-07
Trial Details
NCT Number NCT06853431
Lead Sponsor Second Affiliated Hospital of Wenzhou Medical University
Conditions Preoperative Anxiety, Preoperative Sedation, Children, Dexmedetomidine, Esketamine, ED95, ED50, Preoperative Sedation of Children
Enrollment 80 participants
Start Date 2025-03-01
Primary Completion 2025-11-30 (estimated)
Study Completion 2025-11-30 (estimated)
Updated on ClinicalTrials.gov 2025-12-02