Clinical trial NCT06294639: ED50 of Esketamine for Laser Treatment in Children
Official title: Median Effective Dose (ED50) of Esketamine Combined With Alfentanil for Children to Inhibit Body Movement During Laser Treatment for Facial Lesion
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anesthesia
Keywords: esketamine
children
half effective dose
laser treatment
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: The Biased coin method is used
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: half effective dose of inhibition of body movement
timeFrame: from injection of esketamine to start of laser treatment, in an average of 5 minutes
Secondary outcomes:
measure: number of patients with agitation during awake
timeFrame: from end of injection of esketamine to 30 minutes after laser treatment, in an average of 60 minutes
measure: number of patients with dizzy during awake
timeFrame: from end of injection of esketamine to 30 minutes after laser treatment, in an average of 60 minutes
measure: number of patients with nausea and vomiting during awake
timeFrame: from end of injection of esketamine to 30 minutes after laser treatment, in an average of 60 minutes
measure: number of patients with apnea during awake
timeFrame: from end of injection of esketamine to 30 minutes after laser treatment, in an average of 60 minutes
measure: satisfaction score of the parents to the anesthesia
timeFrame: from end of laser treatment to discharge from the outpatient unit, in an average of 60 minutes
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.