Application of Different Modes of Esketamine Administrati... | NCT05811221

Studies
Application of Different Modes of Esketamine Administration in Pediatric Day Circumcision

NCT05811221

Sponsor

Yangzhou University

Status

Unknown status

Last Update Posted

Apr 13, 2023Actual

Enrollment

70Estimated

Phase

Not Applicable

Conditions

Pain

Interventions

Esketamine of single injection
Esketamine of Intermittent injection

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2, 2023Estimated

Primary Completion Date

May 15, 2023Estimated

Completion Date

Jun 1, 2023Estimated

First Submitted Date

Mar 1, 2023

First Submission Date that Met QC Criteria

Mar 30, 2023

First Posted Date

Apr 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2023

Last Update Posted Date

Apr 13, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Esketamine of single injection	Drug	Single group: give esketamine 0.75 mg/kg at the time of induction	single group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
One-time success rate of anesthesia	No movement during anesthesia	During surgery

Secondary Outcomes

Measure	Description	Time Frame
Systolic blood pressure	Systolic blood pressure	During surgery
Diastolic blood pressure	Diastolic blood pressure	During surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided