Application of Different Modes of Esketamine Administration in Pediatric Day Circumcision

NCT05811221 — Not applicable, Unknown, 70 participants, Yangzhou University

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Registry	NCT05811221
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, other
Enrollment	70 (Estimated)
Sponsor	Yangzhou University (Other)
Conditions	Pain
Interventions	Esketamine of single injection, Esketamine of Intermittent injection (Drug)
Dates	start 2023-04-02 (estimated), primary completion 2023-05-15 (estimated), completion 2023-06-01 (estimated), first posted 2023-04-13, last updated 2023-04-13

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
single group	Active comparator	Drug: Esketamine of single injection	give esketamine 0.75 mg/kg at the time of induction
intermittent group	Experimental	Drug: Esketamine of Intermittent injection	give esketamine 0.5mg/kg during anesthesia induction, and during the measuring ring esketamine 0.25mg/kg was given again

Esketamine of single injection (Drug), also known as A single injection of esketamine at the time of anesthesia induction: Single group: give esketamine 0.75 mg/kg at the time of induction
Esketamine of Intermittent injection (Drug), also known as A Intermittent injection of esketamine at the time of anesthesia induction: Intermittent group: give esketamine 0.5mg/kg during anesthesia induction, and during the measuring ring esketamine 0.25mg/kg was given again

+Outcome measures

Primary outcomes

One-time success rate of anesthesia [During surgery]: No movement during anesthesia

Secondary outcomes

Systolic blood pressure [During surgery]: Systolic blood pressure
Diastolic blood pressure [During surgery]: Diastolic blood pressure
Heart rate [During surgery]: Heart rate
intraoperative propofol dosage, esketamine dosage [During surgery]: intraoperative propofol dosage, esketamine dosage
Duration of surgery [During surgery]: Duration of surgery
Time to open eyes [During surgery]: Time to open eyes
Time to talk [During surgery]: Time to talk
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)

+Eligibility

Sex: Male, ages: 6 Years to 12 Years

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