ED50 of Esketamine for Laser Treatment in Children

Not Applicable

Not yet recruiting

• Conditions: Anesthesia
• Interventions: Drug: Esketamine

• Registration Number: NCT06294639
• Lead Sponsor: Air Force Military Medical University, China

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-28
• Study First Submitted QC: 2024-02-28
• Last Update Submitted: 2024-02-28
• Study First Posted: 2024-03-05
• Last Update Posted: 2024-03-05
• Study Start: 2024-03-27
• Primary Completion: 2025-03-27
• Study Completion: 2025-04-27

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
esketamine	Esketamine	esketamine will be given intravenously

Primary Outcome Measures

Name	Time	Method
half effective dose of inhibition of body movement	from injection of esketamine to start of laser treatment, in an average of 5 minutes

Secondary Outcome Measures

Name	Time	Method
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
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	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
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
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