Anesthesia Clinical Trial
— ESCALATEOfficial 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.
| Status | Not yet recruiting |
| Enrollment | 40 |
| Est. completion date | April 27, 2025 |
| Est. primary completion date | March 27, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 3 Years to 12 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Air Force Military Medical University, China |
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. — View 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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | half effective dose of inhibition of body movement | from injection of esketamine to start of laser treatment, in an average of 5 minutes | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 | from end of laser treatment to discharge from the outpatient unit, in an average of 60 minutes |
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