Application of Different Modes of Esketamine Administration in Pediatric Day Circumcision

Not Applicable

Not yet recruiting

• Conditions: Pain
• Interventions: Drug: Esketamine of Intermittent injection; Drug: Esketamine of single injection

• Registration Number: NCT05811221
• Lead Sponsor: Yangzhou University

Brief Summary

To explore the application of different administration modes of esketamine in pediatric day circumcision, in order to find an anesthesia scheme more suitable for day pediatric circumcision.

Detailed Description

The current clinical study believes that esketamine is suitable for pediatric anesthesia because of its advantages of light respiratory depression, low secretions, low incidence of psychomotor reactions and fast recovery of anesthesia, but there are few related studies on its administration mode and timing in clinical application, this study aims to explore the application of different administration methods of esketamine in pediatric day circumcision, and find an anesthesia scheme more suitable for day circumcision, in order to provide new ideas for anesthesia for pediatric day circumcision.

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-01
• Study First Submitted QC: 2023-03-30
• Last Update Submitted: 2023-03-30
• Study Start: 2023-04-02
• Study First Posted: 2023-04-13
• Last Update Posted: 2023-04-13
• Primary Completion: 2023-05-15
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 70

Inclusion Criteria

• American Society of Anesthesiologists (ASA) class I and II children
• Age 5-12 years
• Foreskin cerclage is proposed
• No history of upper respiratory tract infection in the past two weeks
• Obtain the consent of the child's family

Exclusion Criteria

• Hepatic and renal insufficiency, coagulation dysfunction
• Those who are allergic to esketamine
• History of cognitive impairment
• epilepsy
• other psychiatric and neurological disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intermittent group	Esketamine of Intermittent injection	give esketamine 0.5mg/kg during anesthesia induction, and during the measuring ring esketamine 0.25mg/kg was given again
single group	Esketamine of single injection	give esketamine 0.75 mg/kg at the time of induction

Primary Outcome Measures

Name	Time	Method
One-time success rate of anesthesia	During surgery	No movement during anesthesia

Secondary Outcome Measures

Name	Time	Method
Time to talk	During surgery	Time to talk
Time to open eyes	During surgery	Time to open eyes
intraoperative propofol dosage, esketamine dosage	During surgery	intraoperative propofol dosage, esketamine dosage
Duration of surgery	During surgery	Duration of surgery
Systolic blood pressure	During surgery	Systolic blood pressure
Diastolic blood pressure	During surgery	Diastolic blood pressure
Heart rate	During surgery	Heart rate
VAS(visual analogue scale) score	12 hours after the end of surgery	A score to assess pain, use a swimming ruler about 10 cm long, marked with 10 scales on one side, with "0" and "10" ends at each end, 0 points means no pain, and 10 points represent the most severe pain that is unbearable.
Incidence of adverse effects (hypotension, hypertension, respiratory depression, postoperative pain, diplopia, mania)	12 hours after the end of surgery	Incidence of adverse effects (hypotension, hypertension, respiratory depression, postoperative pain, diplopia, mania)