The Best Dose of Esketamine for Day Surgery of Pediatric Circumcision Pediatric Circumcision

NCT04698434 | Completed

• 1 other identifier: Y015
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

In recent years, daytime operation has been developed gradually in China. Circumcision in children is a common type of daytime operation. The nature of the operation and the object of the operation determine that the anesthetic drugs used should induce fast, wake up quickly and recover in a high quality. Esketamine is an S-enantiomer of ketamine, which is newly marketed in China. Compared with ketamine, it has stronger effect on NMDA receptor, and its sedative effect is about twice as high. The occurrence frequency of respiratory depression and hypotension is lower than that of other anesthetics and analgesics, which can provide good analgesic and sedative effect for surgical anesthesia. In clinical practice, ketamine combined with sevoflurane has been widely used in children's microsurgery, but there has been no report on Esketamine combined with sevoflurane anesthesia. In order to find out the best combined dose, this paper compares the single administration of three different doses of esketamine combined with sevoflurane anesthesia in the circumcision of children.

Conditions

Phimosis

Keywords

Esketamine; Sevoflurane; Children; circumcise

Outcome Measures

Primary Outcomes (1)

• recovery time

  the time from stopping sevoflurane to resuscitation

  up to 2 hour

Secondary Outcomes (1)

• CHEOPS score

  up to 6 hours

Study Arms (3)

0.5mg/kg esketamine group

ACTIVE COMPARATOR

0.5mg/kg esketamine group will be given a single intravenous 0.5mg/kg esketamine

Drug: Esketamine

.75mg/kg esketamine group

ACTIVE COMPARATOR

0.75mg/kg esketamine groupwill be given a single intravenous 0.75mg/kg esketamine

Drug: Esketamine

1.0mg/kg esketamine group

ACTIVE COMPARATOR

1.0mg/kg esketamine group will be given a single intravenous 1.5mg/kg esketamine

Drug: Esketamine

Interventions

Esketamine DRUG

each group was given a single intravenous dose of the corresponding esketamine.

.75mg/kg esketamine group; 0.5mg/kg esketamine group; 1.0mg/kg esketamine group

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• phimosis

You may not qualify if:

• cardiopathy
• asthma
• dysgnosia
• surdimutism
• hepatopathy or nephropathy

Sponsors & Collaborators

• Yangzhou University: lead

Study Sites (1)

Affiliated hospital of yangzhou university

Yangzhou, Jiangsu, 225100, China

Location

MeSH Terms

Conditions

Phimosis

Interventions

Esketamine

Condition Hierarchy (Ancestors)

Penile Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Sun Ji Hong, bachelor

  Yangzhou University

  STUDY CHAIR

Study Design

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

Model Details: children who underwent day surgery of pediatric circumcision were randomly divided into 3 groups according to the random number table method:0.5mg/kg esketamine group (Group A), 0.75mg/kg esketamine group (Group B) and 1.0mg/kg of esketamine group (Group C), with 30 people in each group.

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: January 6, 2021
• Study Start: January 15, 2021
• Primary Completion: February 20, 2021
• Study Completion: March 30, 2021
• Last Updated: February 10, 2022

Record last verified: 2022-02

Locations

CN (1)