Study of Intranasal Dexmedetomidine and Esketamine for Pre-Surgery Sedation in Children Aged 1 to 6 Undergoing General Anesthesia

What this Trial Is About

This research aims to explore the effective dose levels ED50 and ED95 and clinical effects of combining intranasal dexmedetomidine and esketamine for preoperative sedation in children aged 1 to 6 years undergoing general anesthesia. The study focuses on improving sedation compliance to reduce adverse behavioral effects after surgery and provides a theoretical basis for using these drugs together for sedation in pediatric patients. Children are divided into two age groups toddlers 1-3 years and preschool children 3-6 years. Both groups receive an initial intranasal dose of dexmedetomidine 1 gkg combined with esketamine 0.5 mgkg. The dexmedetomidine dose is adjusted in increments of 0.25 gkg based on sedation success using a biased coin design. Sedation depth is assessed every 5 minutes with the Ramsay Sedation Scale, and sedation onset time is recorded. Intravenous cannulation and emotional state assessments occur 30 minutes after drug administration. Participants undergo continuous monitoring of vital signs including blood pressure, heart rate, respiratory rate, and oxygen saturation before and after drug administration. Sedation onset, surgical time, awakening time, and emergence delirium are recorded. The study also evaluates intravenous cannulation success and adverse effects up to 24 hours. The total observation includes perioperative and postoperative periods to assess sedation effectiveness and safety.

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