The Study is Being Conducted to Evaluate the Efficacy and Safety of Dexmedetomidine Hydrochloride Microneedles for Preoperative Sedation in Children

Официальное название

Study on Pharmacokinetics and Clinical Efficacy of Dexmedetomidine Hydrochloride Microneedles(DEX) for Preoperative Sedation in Children

Обзор

The study is being conducted to evaluate the efficacy, safety and the population pharmacokinetic characteristics of Dexmedetomidine Hydrochloride Microneedles for preoperative sedation in children

Подробное описание

A multicenter, randomized, double-blind, placebo-controlled Phase IIa clinical trial, using Dexmedetomidine Hydrochloride Microneedles as an investigational drug and the Dexmedetomidine Hydrochloride Microneedles blank preparation as a comparator. After going through the confirmation of inclusion/exclusion criteria with signed subjects, they will have a procedure either of the two arms. The subjects should follow designated physician's instructions accurately during the clinical trial period.

Вмешательства

• Препарат Dexmedetomidine hydrochloride Microneedles
  Randomized in a 1:1 ratio through the randomization system, and assigned to medium-pressure group or low-pressure group.
• Препарат Dexmedetomidine hydrochloride Microneedles
  In the high weight group, 8 subjects will receive a high dose of Dexmedetomidine hydrochloride Microneedles. In the high weight group, 8 subjects will receive a low dose of Dexmedetomidine hydrochloride Microneedles.
• Препарат placebo
  In the high weight group, 8 subjects will receive Dexmedetomidine hydrochloride Microneedles blank preparation.
• Препарат Dexmedetomidine hydrochloride Microneedles
  In the low weight group, 8 subjects will receive a low dose of Dexmedetomidine hydrochloride Microneedles. In the low weight group, 8 subjects will receive a high dose of Dexmedetomidine hydrochloride Microneedles.
• Препарат Placebo
  In the low weight group, 8 subjects will receive Dexmedetomidine hydrochloride Microneedles blank preparation.

Первичные конечные точки

• Adverse Event and Serious Adverse Event [Срок оценки: Day2]

Вторичные конечные точки (3)

• Maximum blood concentration [Срок оценки: 0 to 4 hour after administration]
• Ramsay scale [Срок оценки: 0 minute to 45 minutes after administration]
• Sedation Success Rate [Срок оценки: 0 minute to 45 minutes after administration]

Критерии участия

Критерии включения

• Aged 2 years to 6 years (inclusive ), any genders;
• Body weight meeting the criteria:
• Scheduled to undergo general anesthesia for surgery/procedure
• American Society of Anesthesiologists（ASA） I\~II
• Provide written informed consent from the legal guardian

Критерии исключения

• Allergy to any component of the Dexmedetomidine Hydrochloride Microneedle Patch, history of allergy to other sedative drugs, or known allergy to α2-adrenergic receptor-related products or excipients;
• Having received other sedative-hypnotic or analgesic drugs prior to randomization, where the time since last dose is less than 7 half-lives;
• History of bronchial asthma, chronic respiratory diseases, or other severe respiratory system diseases;
• History of neurological diseases such as ischemic encephalopathy encephalopathy, craniocerebral injury, etc., which in the investigator's judgment may affect the evaluation of the investigational product;
• History of thoracic, cardiac, or brain surgery;
• Presence of large areas of skin damage or skin conditions unsuitable for topical patch application on the inner aspects of both forearms or the outer aspects of both thighs;
• Abnormal liver/kidney function test values (ALT or AST >1.5 times the upper limit of normal \[ULN\], or bilirubin >1.5 × ULN, or serum creatinine >1.5 × ULN);
• Severe cardiovascular diseases (e.g., fulminant myocarditis, high-grade or third-degree atrioventricular block, sick sinus syndrome, severe arrhythmia, cardiomyopathy, severe pulmonary hypertension, pulmonary atresia, heart failure);
• Anemia requiring treatment, as judged by the investigator (hemoglobin <80 g/L);
• Use of highly selective α2 agonists or antagonists prior to randomization, where the time since last dose is less than 7 half-lives;
• Participation in another clinical trial (meaning having received an investigational drug or device) within 3 months prior to screening;
• Presence of severe psychiatric illness at screening leading to inability or unwillingness to cooperate;
• Other situations deemed by the investigator as unsuitable for inclusion.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital) — Гуанчжоу

Идентификаторы

NCT: NCT07168720 · BOJI2025016LH

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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