NCT05811221

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable pain

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

April 2, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 13, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2023

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

April 13, 2023

Status Verified

March 1, 2023

Enrollment Period

1 month

First QC Date

March 1, 2023

Last Update Submit

March 30, 2023

Conditions

Pain

Keywords

Pediatric circumcisionMode of administrationDay surgeryEsketamine

Outcome Measures

Primary Outcomes (1)

  • One-time success rate of anesthesia

    No movement during anesthesia

    During surgery

Secondary Outcomes (9)

  • Systolic blood pressure

    During surgery

  • Diastolic blood pressure

    During surgery

  • Heart rate

    During surgery

  • intraoperative propofol dosage, esketamine dosage

    During surgery

  • Duration of surgery

    During surgery

  • +4 more secondary outcomes

Study Arms (2)

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

Esketamine of single injectionDRUG

Single group: give esketamine 0.75 mg/kg at the time of induction

Also known as: A single injection of esketamine at the time of anesthesia induction
single group
Esketamine of Intermittent injectionDRUG

Intermittent group: give esketamine 0.5mg/kg during anesthesia induction, and during the measuring ring esketamine 0.25mg/kg was given again

Also known as: A Intermittent injection of esketamine at the time of anesthesia induction
intermittent group

Eligibility Criteria

Age6 Years - 12 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 1, 2023

First Posted

April 13, 2023

Study Start

April 2, 2023

Primary Completion

May 15, 2023

Study Completion

June 1, 2023

Last Updated

April 13, 2023

Record last verified: 2023-03