Recruiting
Phase 2
The Study is Being Conducted to Evaluate the Efficacy and Safety of Dexmedetomidine Hydrochloride Microneedles for Preoperative Sedation in Children
Condition(s) studied
Preoperative Sedation
Investigational drug(s) / intervention(s)
Dexmedetomidine hydrochloride MicroneedlesDexmedetomidine hydrochloride MicroneedlesplaceboDexmedetomidine hydrochloride MicroneedlesPlacebo
Dexmedetomidine hydrochloride Microneedles: Randomized in a 1:1 ratio through the randomization system, and assigned to medium-pressure group or low-pressure group.
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.
placebo: In the high weight group, 8 subjects will receive Dexmedetomidine hydrochloride Microneedles blank preparation.
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.
Placebo: In the low weight group, 8 subjects will receive Dexmedetomidine hydrochloride Microneedles blank preparation.
Study summary
The study is being conducted to evaluate the efficacy, safety and the population pharmacokinetic characteristics of Dexmedetomidine Hydrochloride Microneedles for preoperative sedation in children
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.
Primary outcome measure(s)
- Adverse Event and Serious Adverse Event — Day2
Incidence rate of Adverse Event and Serious Adverse Event
Trial sites (1)
| Facility | City | Region | Status |
|---|
| The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital) |
Guangzhou |
Guangdong |
Recruiting |
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