ED50 of Esketamine for Laser Treatment in Children

NCT06294639 | Not Yet Recruiting

• 1 other identifier: XJA-20240224
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Keywords

esketamine; children; half effective dose; laser treatment

Outcome Measures

Primary Outcomes (1)

• half effective dose of inhibition of body movement

  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

  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

  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

  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

  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

  from end of laser treatment to discharge from the outpatient unit, in an average of 60 minutes

Study Arms (1)

esketamine

EXPERIMENTAL

esketamine will be given intravenously

Drug: Esketamine

Interventions

Esketamine DRUG

esketamine will be given intravenously

Also known as: intravenous esketamine

esketamine

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Related Publications (3)

• 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.

  PMID: 38317070 BACKGROUND

• 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.

  PMID: 37464290 BACKGROUND

• 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.

  PMID: 35255530 BACKGROUND

MeSH Terms

Interventions

Esketamine

Central Study Contacts

Zhi-Hong Lu

CONTACT

+862984775343; deerlu23@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: The Biased coin method is used

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 5, 2024
• Study Start: March 27, 2024
• Primary Completion: March 27, 2025
• Study Completion: April 27, 2025
• Last Updated: March 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: after publication of the results
• Access Criteria: sending email to deerlu23@163.com