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

RecruitingPhase 4Ages 12 Months - 72 MonthsAllSecond Affiliated Hospital of Wenzhou Medical Uni…
NCT06853431 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. ASA physical status classification Grade I or II; 2. Age 1-6 years old; 3. Children who need to undergo general anesthesia for elective surgery; 4. Weight within the normal range; 5. Signed informed consent form. - Exclusion Criteria: 1. The child's guardian or the child themselves refuses to participate in the study; 2. Patients with contraindications for sedation/anesthesia or a history of abnormal recovery from sedation/anesthesia; 3. Individuals known to be allergic to the study drugs, opioid drugs, or rescue medications; 4. Individuals with a history of heart, brain, liver, kidney, or metabolic diseases; 5. Individuals with an upper respiratory tract infection within the past two weeks; 6. Individuals with other diseases that may cause harm to the subject. -
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What it tests

  • dexmedetomidine
  • Esketamine
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Where

2 sites
The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, China
The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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