Preoperative SedationPhase 2NCT07168720
The Study is Being Conducted to Evaluate the Efficacy and Safety of Dexmedetomidine Hydrochloride Microneedles for Preoperative Sedation in Children
A Phase 2 study testing Dexmedetomidine hydrochloride Microneedles in people with Preoperative Sedation, run by Guangzhou Novaken Pharm Co., Ltd. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Preoperative Sedation
- What is being tested?
- Dexmedetomidine hydrochloride Microneedles
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 29 Aug 2025to 30 Apr 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital)
Guangzhou, Guangdong, 510632
Hao Wang, Doctor, 011-86-15521329479, haowang@jnu.edu.cn
About this study
Official title: Study on Pharmacokinetics and Clinical Efficacy of Dexmedetomidine Hydrochloride Microneedles(DEX) for Preoperative Sedation in Children
The study is being conducted to evaluate the efficacy, safety and the population pharmacokinetic characteristics of Dexmedetomidine Hydrochloride Microneedles for preoperative sedation in children
Read the 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.
- Conditions
- Preoperative Sedation
- Being tested
- Dexmedetomidine hydrochloride Microneedles, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine hydrochloride MicroneedlesDrug
Randomized in a 1:1 ratio through the randomization system, and assigned to medium-pressure group or low-pressure group.
Dexmedetomidine hydrochloride MicroneedlesDrug
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.
placeboDrug
In the high weight group, 8 subjects will receive Dexmedetomidine hydrochloride Microneedles blank preparation.
Dexmedetomidine hydrochloride MicroneedlesDrug
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.
PlaceboDrug
In the low weight group, 8 subjects will receive Dexmedetomidine hydrochloride Microneedles blank preparation.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | 16 Participants will receive the Dexmedetomidine hydrochloride Microneedles identified in Part 1 of the study. Randomized in a 1:1 ratio through the randomization system, and assigned to medium-pressure group or low-pressure group. A total of 16 children with a high body weight (weight ≥ 19.4 kg) will be included. They will be randomly divided into a medium-pressure group and a low-pressure at a ratio of 1:1. Receives: Drug: Dexmedetomidine hydrochloride Microneedles |
| part2 | Experimental | Participants will receive the dose identified in Part 1 of the study. A total of 24 children with high body weight (weighing less than 19.4 kg) will be included. They will be randomly divided into the low dose group , the high dose group and placebo group at a ratio of 1:1:1. They will be given Dexmedetomidine hydrochloride Microneedles or placebo. Receives: Drug: Dexmedetomidine hydrochloride Microneedles; Drug: placebo |
| part3 | Experimental | Participants will receive the dose identified in Part 2 of the study. A total of 24 children with low body weight (weighing less than 19.4 kg) will be included. They will be randomly divided into the low dose group , the high dose group and placebo group at a ratio of 1:1:1. They will be given Dexmedetomidine hydrochloride Microneedles or placebo. Receives: Drug: Dexmedetomidine hydrochloride Microneedles; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event and Serious Adverse Event
Incidence rate of Adverse Event and Serious Adverse Event
Measured: Day2
Secondary outcomes (3)
Maximum blood concentration
Maximum blood concentration
Measured: 0 to 4 hour after administration
Ramsay scale
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.
Measured: 0 minute to 45 minutes after administration
Sedation Success Rate
Proportion of subjects who will accomplish to start the anesthetic indcution or medical procedure
Measured: 0 minute to 45 minutes after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start29 Aug 2025
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative SedationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Novaken Pharm Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168720
- Sponsor's protocol ID
- BOJI2025016LH
- Status last verified
- Sep 2025
- First submitted
- 27 Aug 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.