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

Inclusion Criteria5

  • ASA physical status classification Grade I or II;
  • Age 1-6 years old;
  • Children who need to undergo general anesthesia for elective surgery;
  • Weight within the normal range;
  • Signed informed consent form. -

Exclusion Criteria6

  • The child's guardian or the child themselves refuses to participate in the study;
  • Patients with contraindications for sedation/anesthesia or a history of abnormal recovery from sedation/anesthesia;
  • Individuals known to be allergic to the study drugs, opioid drugs, or rescue medications;
  • Individuals with a history of heart, brain, liver, kidney, or metabolic diseases;
  • Individuals with an upper respiratory tract infection within the past two weeks;
  • Individuals with other diseases that may cause harm to the subject. -

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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