Preoperative Sedation
Conditions
Brief 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
Detailed 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.
Interventions
DRUGDexmedetomidine hydrochloride Microneedles
Randomized in a 1:1 ratio through the randomization system, and assigned to medium-pressure group or low-pressure group.
DRUGplacebo
In the high weight group, 8 subjects will receive Dexmedetomidine hydrochloride Microneedles blank preparation.
DRUGPlacebo
In the low weight group, 8 subjects will receive Dexmedetomidine hydrochloride Microneedles blank preparation.
Sponsors
Guangzhou Novaken Pharm Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event and Serious Adverse Event | Day2 | Incidence rate of Adverse Event and Serious Adverse Event |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum blood concentration | 0 to 4 hour after administration | Maximum blood concentration |
| Ramsay scale | 0 minute to 45 minutes after administration | Sedation level using the Ramsay scale. Ramsay Satisfaction defined as a scale of 1,2, 3, 4,5,6; the minimum value is 1 , the maximum value is 6, higher scores mean a better outcome. |
| Sedation Success Rate | 0 minute to 45 minutes after administration | Proportion of subjects who will accomplish to start the anesthetic indcution or medical procedure |
Countries
China
Contacts
Primary ContactHuaLiang Liu, Master
Outcome results
None listed