Preoperative SedationPhase 1NCT04200235
A Trial of Dexmedetomidine Hydrochloride Nasal Spray in Preoperative Sedation of Children
A Phase 1 study testing Dexmedetomidine hydrochloride nasal spray and Dexmedetomidine hydrochloride nasal spray blank preparation. in people with Preoperative Sedation, run by Jiangsu HengRui Medicine 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 nasal spray 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 nasal spray and Dexmedetomidine hydrochloride nasal spray blank preparation.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 6 Jan 2020to 7 Aug 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Able and willing to provide a written informed consent
- Male or female
- Subjects requiring elective general anesthesia surgery
- Conform to the ASA Physical Status Classification
- Meet the weight standard
Who cannot join
- Not suitable for nasal spray
- Pediatric populations requiring special care or court/social welfare supervision
- Subjects who had been under general anesthesia were randomized
- Subjects with mental disorders and cognitive impairment；Subject with a history of epilepsy
- Subjects with previous abnormal behavior after medication
- Subjects with cardiovascular disease
Show all 13Show fewer
- Clinically significant abnormal clinical laboratory test value
- Subjects whose hemoglobin is below the lower limit of normal
- Subjects who have either an adrenergic receptor agonist or an antagonist were randomized
- Participated in clinical trials of other drugs before screening (accepted experimental drugs)
- A history or possibility of difficult airway
- History of hypersensitivity to drug ingredients or components
- Other circumstances that the investigator judged inappropriate for participation in this clinical trial
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing children's hospital, capital medical university
Beijing, Beijing Municipality, 100045
About this study
Official title: Study on Pharmacokinetics and Clinical Efficacy of Dexmedetomidine Hydrochloride Nasal Spray for Preoperative Sedation in Children
The study is being conducted to evaluate the efficacy, safety and the population pharmacokinetic characteristics of dexmedetomidine hydrochloride nasal spray for preoperative sedation in children
- Conditions
- Preoperative Sedation
- Being tested
- Dexmedetomidine hydrochloride nasal spray, Dexmedetomidine hydrochloride nasal spray blank preparation.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine hydrochloride nasal sprayDrug
In the low weight group, 18 subjects will receive a low dose of dexmedetomidine nasal spray.
In the high weight group, 18 subjects will receive a high dose of dexmedetomidine nasal spray.
Dexmedetomidine hydrochloride nasal spray blank preparation.Drug
Also called Placebo
In the low weight group, 6 subjects will receive dexmedetomidine hydrochloride nasal spray blank preparation.
In the high weight group, 6 subjects will receive dexmedetomidine hydrochloride nasal spray blank preparation.
| Study group | Role | What they receive |
|---|---|---|
| High weight group | Experimental | High weight group Receives: Drug: Dexmedetomidine hydrochloride nasal spray; Drug: Dexmedetomidine hydrochloride nasal spray blank preparation. |
| Low weight group | Experimental | Low weight group Receives: Drug: Dexmedetomidine hydrochloride nasal spray; Drug: Dexmedetomidine hydrochloride nasal spray blank preparation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK Cmax
Maximum blood concentration (Cmax)
Measured: 0 to 1 hour after administration
Secondary outcomes (7)
Proportion of subjects who parent-child separation successful
The FUNK scale is a scale of 1 to 4 for sedation, anxiety, and separation from parents. Separation success defined as a scale of 3 or 4 per item.
Measured: 0 minute to 45 minutes after administration: every 15 minutes after administration
Proportion of subjects who the Ramsay score is satisfactory at least once
Sedation level using the Ramsay scale. Ramsay Satisfaction defined as a scale of 2, 3, or 4;
Measured: 0 minute to 45 minutes after administration: every 5 minutes after administration
Proportion of subjects who the UMSS Scale is satisfactory at least once
Sedation level using the University of Michigan Sedation Scale. UMSS satisfaction defined as a scale of 3, 4, 5, or 6;
Measured: 0 minute to 45 minutes after administration: every 5 minutes after administration
Total consumption of propofol(mg) during general anesthesia
Total consumption of propofol(mg) during general anesthesia
Measured: From the beginning of anesthesia to the end of surgical operation up to 4 hours
Total consumption of opioid analgesic(μg) during general anesthesia
Total consumption of opioid analgesic(μg) during general anesthesia
Measured: From the beginning of anesthesia to the end of surgical operation up to 4 hours
Time of anesthesia awakening
Time of anesthesia awakening
Measured: Up to 4 hours after the end of surgical operation
Proportion of subjects with postoperative agitation
Proportion of subjects with postoperative agitation
Measured: Up to 4 hours after the end of surgical operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start6 Jan 2020
- Primary completion6 Aug 2020
- Study completion7 Aug 2020
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.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Dexmedetomidine hydrochloride nasal spray compared with placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04200235
- Sponsor's protocol ID
- HR0171401-102
- Status last verified
- Nov 2019
- First submitted
- 25 Nov 2019
- Last updated
- 9 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Pharmacokinetics and Clinical Efficacy of Dexmedetomidine Hydrochloride Nasal Spray for Preoperative Sedation in Children
- ClinicalTrials.gov ID
- NCT04200235
- Acronym / sponsor ID
- HR0171401-102
- Conditions
- Preoperative Sedation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 6 Aug 2020 (actual)
- Study completion
- 7 Aug 2020 (actual)
- First posted
- 16 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is being conducted to evaluate the efficacy, safety and the population pharmacokinetic characteristics of dexmedetomidine hydrochloride nasal spray for preoperative sedation in children
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Dexmedetomidine hydrochloride nasal spray compared with placebo
| Arm | Type | Receives |
|---|---|---|
| High weight group | Experimental | Drug: Dexmedetomidine hydrochloride nasal spray, Drug: Dexmedetomidine hydrochloride nasal spray blank preparation.High weight group |
| Low weight group | Experimental | Drug: Dexmedetomidine hydrochloride nasal spray, Drug: Dexmedetomidine hydrochloride nasal spray blank preparation.Low weight group |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Able and willing to provide a written informed consent
- Male or female
- Subjects requiring elective general anesthesia surgery
- Conform to the ASA Physical Status Classification
- Meet the weight standard
Key exclusion criteria (13 listed)
- Not suitable for nasal spray
- Pediatric populations requiring special care or court/social welfare supervision
- Subjects who had been under general anesthesia were randomized
- Subjects with mental disorders and cognitive impairment；Subject with a history of epilepsy
- Subjects with previous abnormal behavior after medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine hydrochloride nasal sprayIn the low weight group, 18 subjects will receive a low dose of dexmedetomidine nasal spray. In the high weight group, 18 subjects will receive a high dose of dexmedetomidine nasal spray. | Drug | High weight group, Low weight group |
| Dexmedetomidine hydrochloride nasal spray blank preparation.Also: PlaceboIn the low weight group, 6 subjects will receive dexmedetomidine hydrochloride nasal spray blank preparation. In the high weight group, 6 subjects will receive dexmedetomidine hydrochloride nasal spray blank preparation. | Drug | High weight group, Low weight group |
Primary outcome
PK Cmax
Time frame: 0 to 1 hour after administration
Maximum blood concentration (Cmax)
7 secondary outcomes
Proportion of subjects who parent-child separation successful
Time frame: 0 minute to 45 minutes after administration: every 15 minutes after administration
Proportion of subjects who the Ramsay score is satisfactory at least once
Time frame: 0 minute to 45 minutes after administration: every 5 minutes after administration
Proportion of subjects who the UMSS Scale is satisfactory at least once
Time frame: 0 minute to 45 minutes after administration: every 5 minutes after administration
Total consumption of propofol(mg) during general anesthesia
Time frame: From the beginning of anesthesia to the end of surgical operation up to 4 hours
Total consumption of opioid analgesic(μg) during general anesthesia
Time frame: From the beginning of anesthesia to the end of surgical operation up to 4 hours
Time of anesthesia awakening
Time frame: Up to 4 hours after the end of surgical operation
Proportion of subjects with postoperative agitation
Time frame: Up to 4 hours after the end of surgical operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dexmedetomidine hydrochloride nasal spray and Dexmedetomidine hydrochloride nasal spray blank preparation. in people with Preoperative Sedation, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK Cmax (time frame: 0 to 1 hour after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.