Overview
The study is being conducted to evaluate the efficacy, safety and the population pharmacokinetic characteristics of Dexmedetomidine Hydrochloride Microneedles for preoperative sedation in children
Description
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.
Eligibility
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.