ED50 of Esketamine for Laser Treatment in Children

NCT ID: NCT06294639

Last Updated: 2024-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-27

Study Completion Date

2025-04-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SEQUENTIAL

The Biased coin method is used
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Esketamine will be prepared by an investigator who is not involved in anesthesia and outcome assessment. For all participants, esketamine will be diluted to the same volume.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

esketamine

esketamine will be given intravenously

Group Type EXPERIMENTAL

Esketamine

Intervention Type DRUG

esketamine will be given intravenously

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Esketamine

esketamine will be given intravenously

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

intravenous esketamine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* age between 3 years and 12 years old
* patients scheduled for laser treatment of facial lesion

Exclusion Criteria

* 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
Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Air Force Military Medical University, China

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zhihong LU

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Zhi-Hong Lu

Role: CONTACT

+862984775343

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 38317070 (View on PubMed)

Su 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.

Reference Type BACKGROUND
PMID: 37464290 (View on PubMed)

Zheng 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.

Reference Type BACKGROUND
PMID: 35255530 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

XJA-20240224

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Oral Dexmedetomidine in Pediatric MRI
NCT05619627 NOT_YET_RECRUITING PHASE1
Safety and Efficacy Evaluation of S (+) - Ketamine in Children
NCT04834427 ENROLLING_BY_INVITATION PHASE4