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

ConditionPreoperative Sedation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age2-6
SponsorGuangzhou Novaken Pharm Co., Ltd.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 2 years to 6 years (inclusive ), any genders;

Scheduled to undergo general anesthesia for surgery/procedure

American Society of Anesthesiologists（ASA） I~II

Provide written informed consent from the legal guardian

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexmedetomidine hydrochloride Microneedles

    Drug

    Randomized in a 1:1 ratio through the randomization system, and assigned to medium-pressure group or low-pressure group.

  • Dexmedetomidine hydrochloride Microneedles

    Drug

    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

    Drug

    In the high weight group, 8 subjects will receive Dexmedetomidine hydrochloride Microneedles blank preparation.

  • Dexmedetomidine hydrochloride Microneedles

    Drug

    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

    Drug

    In the low weight group, 8 subjects will receive Dexmedetomidine hydrochloride Microneedles blank preparation.

Treatment groups

64 Participants
are divided into 3 treatment groups
Group A: Part 1Experimental treatment 1 intervention
Group B: part2Experimental treatment 2 interventions
Group C: part3Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Adverse Event and Serious Adverse Event

Incidence rate of Adverse Event and Serious Adverse Event

Time frame
Day2

Secondary outcomes

1

Maximum blood concentration

Maximum blood concentration

Time frame
0 to 4 hour after administration
2

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.

Time frame
0 minute to 45 minutes after administration
3

Sedation Success Rate

Proportion of subjects who will accomplish to start the anesthetic indcution or medical procedure

Time frame
0 minute to 45 minutes after administration

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangzhou Novaken Pharm Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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