RecruitingPhase 4NCT06853431

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


Sponsor

Second Affiliated Hospital of Wenzhou Medical University

Enrollment

80 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 12 MonthsMax Age: 72 Months

Plain Language Summary

Simplified for easier understanding

This study determines the right dose of two sedative medications — dexmedetomidine and esketamine, given through the nose — to safely calm young children before they receive general anesthesia for surgery. **You may be eligible if:** - Your child is between 1 and 6 years old - Your child needs to have a planned (non-emergency) surgery under general anesthesia - Your child is generally healthy or has only mild health issues (ASA Class I or II) - Your child's weight is within the normal range for their age - You have signed consent for participation **You may NOT be eligible if:** - You or your child refuses to participate - Your child has a known allergy to the study medications or other anesthetics - Your child has a history of heart, brain, liver, kidney, or metabolic disease - Your child had an upper respiratory infection (cold) in the past two weeks - Your child has had an abnormal reaction to anesthesia in the past Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGdexmedetomidine

esketamine 0.5mg/kg intranasally via a nasal dropper, dexmedetomidine 1μg/kg was given intranasally, and the adjusted dose of dexmedetomidine was 0.25μg/kg.

DRUGEsketamine

esketamine 0.5mg/kg intranasally via a nasal dropper, dexmedetomidine 1μg/kg was given intranasally, and the adjusted dose of dexmedetomidine was 0.25μg/kg.


Locations(2)

The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

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NCT06853431


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