AnesthesiaESCALATENCT06294639
ED50 of Esketamine for Laser Treatment in Children
A study testing Esketamine in people with Anesthesia, run by Air Force Military Medical University, China.
Trial summary
There is limited research on the combined use of esketamine and alfentanil for anesthesia during facial laser treatment in pediatric patients, and the effective dosage of esketamine for inhibiting body movement remains unclear. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Esketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 27 Mar 2024to 27 Apr 2025
- Phase
- Interventional
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age between 3 years and 12 years old
- patients scheduled for laser treatment of facial lesion
Who cannot join
- patients with airway infection during the last 1 month
- patients with cardiac or pulmonary disorder
- patients with hepatic or renal disfunction
- patients with neurologic or psychiatric disorder
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Median Effective Dose (ED50) of Esketamine Combined With Alfentanil for Children to Inhibit Body Movement During Laser Treatment for Facial Lesion
There is limited research on the combined use of esketamine and alfentanil for anesthesia during facial laser treatment in pediatric patients, and the effective dosage of esketamine for inhibiting body movement remains unclear. We explore the effective dose of esketamine combined with alfentanil for the inhibition of body movement during facial laser treatment in pediatric patients.
- Conditions
- Anesthesia
- Being tested
- Esketamine
- Keywords
- esketamine, children, half effective dose, laser treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsketamineDrug
Also called intravenous esketamine
esketamine will be given intravenously
| Study group | Role | What they receive |
|---|---|---|
| esketamine | Experimental | esketamine will be given intravenously Receives: Drug: Esketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
half effective dose of inhibition of body movement
Measured: from injection of esketamine to start of laser treatment, in an average of 5 minutes
Secondary outcomes (5)
number of patients with agitation during awake
Measured: from end of injection of esketamine to 30 minutes after laser treatment, in an average of 60 minutes
number of patients with dizzy during awake
Measured: from end of injection of esketamine to 30 minutes after laser treatment, in an average of 60 minutes
number of patients with nausea and vomiting during awake
Measured: from end of injection of esketamine to 30 minutes after laser treatment, in an average of 60 minutes
number of patients with apnea during awake
Measured: from end of injection of esketamine to 30 minutes after laser treatment, in an average of 60 minutes
satisfaction score of the parents to the anesthesia
The satisfaction of the parents to the anesthesia will be assessed by visual analogue scale, of which 0 is for extremely not satisfied, 10 is for extremely satisfied
Measured: from end of laser treatment to discharge from the outpatient unit, in an average of 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start27 Mar 2024 (estimated)
- Primary completion27 Mar 2025 (estimated)
- Study completion27 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- The Biased coin method is used
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhihong LU, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294639
- Sponsor's protocol ID
- XJA-20240224
- Acronym
- ESCALATE
- Status last verified
- Feb 2024
- First submitted
- 28 Feb 2024
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data could be shared with request to Prof. Zhihong Lu after publication of the results
Publications
Zhang B, Li M, Han Y, Zhao X, Duan C, Wang J. Effective dose of propofol combined with intravenous esketamine for smooth flexible laryngeal mask airway insertion in two distinct age groups of preschool children. BMC Anesthesiol. 2024 Feb 5;24(1):50. doi: 10.1186/s12871-024-02421-z.
PubMed 38317070Su M, Zhu Y, Liu S, Song L, Qu J, Zhang Y, Zhang Q. Median effective dose (ED50) of esketamine combined with propofol for children to inhibit response of gastroscope insertion. BMC Anesthesiol. 2023 Jul 18;23(1):240. doi: 10.1186/s12871-023-02204-y.
PubMed 37464290Zheng XS, Shen Y, Yang YY, He P, Wang YT, Tao YY, Zheng JJ, Sun Y. ED50 and ED95 of propofol combined with different doses of esketamine for children undergoing upper gastrointestinal endoscopy: A prospective dose-finding study using up-and-down sequential allocation method. J Clin Pharm Ther. 2022 Jul;47(7):1002-1009. doi: 10.1111/jcpt.13635. Epub 2022 Mar 7.
PubMed 35255530
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Median Effective Dose (ED50) of Esketamine Combined With Alfentanil for Children to Inhibit Body Movement During Laser Treatment for Facial Lesion
- ClinicalTrials.gov ID
- NCT06294639
- Acronym / sponsor ID
- ESCALATE / XJA-20240224
- Conditions
- Anesthesia
- Keywords
- esketamine, children, half effective dose, laser treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 27 Mar 2024 (estimated)
- Primary completion
- 27 Mar 2025 (estimated)
- Study completion
- 27 Apr 2025 (estimated)
- First posted
- 5 Mar 2024 (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.
There is limited research on the combined use of esketamine and alfentanil for anesthesia during facial laser treatment in pediatric patients, and the effective dosage of esketamine for inhibiting body movement remains unclear. We explore the effective dose of esketamine combined with alfentanil for the inhibition of body movement during facial laser treatment in pediatric patients.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The Biased coin method is used
| Arm | Type | Receives |
|---|---|---|
| esketamine | Experimental | Drug: Esketamineesketamine will be given intravenously |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- age between 3 years and 12 years old
- patients scheduled for laser treatment of facial lesion
Key exclusion criteria (4 listed)
- patients with airway infection during the last 1 month
- patients with cardiac or pulmonary disorder
- patients with hepatic or renal disfunction
- patients with neurologic or psychiatric disorder
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 |
|---|---|---|
| EsketamineAlso: intravenous esketamineesketamine will be given intravenously | Drug | esketamine |
Primary outcome
half effective dose of inhibition of body movement
Time frame: from injection of esketamine to start of laser treatment, in an average of 5 minutes
5 secondary outcomes
number of patients with agitation during awake
Time frame: from end of injection of esketamine to 30 minutes after laser treatment, in an average of 60 minutes
number of patients with dizzy during awake
Time frame: from end of injection of esketamine to 30 minutes after laser treatment, in an average of 60 minutes
number of patients with nausea and vomiting during awake
Time frame: from end of injection of esketamine to 30 minutes after laser treatment, in an average of 60 minutes
number of patients with apnea during awake
Time frame: from end of injection of esketamine to 30 minutes after laser treatment, in an average of 60 minutes
satisfaction score of the parents to the anesthesia
Time frame: from end of laser treatment to discharge from the outpatient unit, in an average of 60 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Background: PubMed 38317070Zhang B, Li M, Han Y, Zhao X, Duan C, Wang J. Effective dose of propofol combined with intravenous esketamine for smooth flexible laryngeal mask airway insertion in two distinct age groups of preschool children. BMC Anesthesiol. 2024 Feb 5;24(1):50. doi: 10.1186/s12871-024-02421-z.
- Background: PubMed 37464290Su M, Zhu Y, Liu S, Song L, Qu J, Zhang Y, Zhang Q. Median effective dose (ED50) of esketamine combined with propofol for children to inhibit response of gastroscope insertion. BMC Anesthesiol. 2023 Jul 18;23(1):240. doi: 10.1186/s12871-023-02204-y.
- Background: PubMed 35255530Zheng XS, Shen Y, Yang YY, He P, Wang YT, Tao YY, Zheng JJ, Sun Y. ED50 and ED95 of propofol combined with different doses of esketamine for children undergoing upper gastrointestinal endoscopy: A prospective dose-finding study using up-and-down sequential allocation method. J Clin Pharm Ther. 2022 Jul;47(7):1002-1009. doi: 10.1111/jcpt.13635. Epub 2022 Mar 7.
- Individual participant dataSharing planned: Yes. The data could be shared with request to Prof. Zhihong Lu after publication of the results
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Esketamine in people with Anesthesia, run by Air Force Military Medical University, 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhi-Hong Lu (+862984775343, deerlu23@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
half effective dose of inhibition of body movement (time frame: from injection of esketamine to start of laser treatment, in an average of 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06294639, which also lists 3 linked publications.
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 5 Mar 2024.