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Recruiting NCT07168720

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

Phase II Interventional Preoperative Sedation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dexmedetomidine hydrochloride Microneedles, Dexmedetomidine hydrochloride Microneedles, placebo, Dexmedetomidine hydrochloride Microneedles.
Who it may be relevant to
Registry conditions: Preoperative Sedation. Basic parameters: 2 years — 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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

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

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

Primary outcome measures

  • Adverse Event and Serious Adverse Event [Time frame: Day2]
Secondary outcome measures (3)
  • Maximum blood concentration [Time frame: 0 to 4 hour after administration]
  • Ramsay scale [Time frame: 0 minute to 45 minutes after administration]
  • Sedation Success Rate [Time frame: 0 minute to 45 minutes after administration]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital) — Guangzhou

Identifiers

NCT: NCT07168720 · BOJI2025016LH

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗