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

Primary Purpose

Phimosis

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Esketamine
Sponsored by
Yangzhou University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Phimosis focused on measuring Esketamine, Sevoflurane, Children, circumcise

Eligibility Criteria

4 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • phimosis

Exclusion Criteria:

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

Sites / Locations

  • Affiliated hospital of yangzhou university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

0.5mg/kg esketamine group

.75mg/kg esketamine group

1.0mg/kg esketamine group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

recovery time
the time from stopping sevoflurane to resuscitation

Secondary Outcome Measures

CHEOPS score
The Eastern Ontario Children's Hospital Pain Score (CHEOPS score) at the time of 2h and 6h after surgery

Full Information

First Posted
July 31, 2020
Last Updated
February 8, 2022
Sponsor
Yangzhou University
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1. Study Identification

Unique Protocol Identification Number
NCT04698434
Brief Title
The Best Dose of Esketamine for Day Surgery of Pediatric Circumcision Pediatric Circumcision
Official Title
The Best Dose of Esketamine for Day Surgery of Pediatric Circumcision
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
February 20, 2021 (Actual)
Study Completion Date
March 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yangzhou University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
To investigate the optimal dose of esketamine combined with sevoflurane for pediatric circumcision. Methods 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. mask inhalation of sevoflurane anesthesia, each group was given a single intravenous dose of the corresponding esketamine. Heart rate (HR), mean arterial pressure (MAP), pulse oxygen saturation (SpO2) and respiratory rate (RR) were recorded at room entry (T0), intravenous ketamine administration (T1), operation initiation (T2), intraoperative central ligation (T3) and operation completion (T4).The number and total amount of ketamine added intraoperatively were recorded. Duration of operation, time to open eyes and time to answer were recorded. The Eastern Ontario Children's Hospital pain Score (CHEOPS score) and the modified Bieri pain score were recorded when awake, 2 hours and 6 hours postoperatie. MOAA/S score was recorded at 15, 30 and 60min after surgery. Intraoperative and post-operative adverse reactions were recorded, including hypersensitivity, agitation, nausea and vomiting, dizziness, diplopia, etc.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phimosis
Keywords
Esketamine, Sevoflurane, Children, circumcise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.5mg/kg esketamine group
Arm Type
Active Comparator
Arm Description
0.5mg/kg esketamine group will be given a single intravenous 0.5mg/kg esketamine
Arm Title
.75mg/kg esketamine group
Arm Type
Active Comparator
Arm Description
0.75mg/kg esketamine groupwill be given a single intravenous 0.75mg/kg esketamine
Arm Title
1.0mg/kg esketamine group
Arm Type
Active Comparator
Arm Description
1.0mg/kg esketamine group will be given a single intravenous 1.5mg/kg esketamine
Intervention Type
Drug
Intervention Name(s)
Esketamine
Intervention Description
each group was given a single intravenous dose of the corresponding esketamine.
Primary Outcome Measure Information:
Title
recovery time
Description
the time from stopping sevoflurane to resuscitation
Time Frame
up to 2 hour
Secondary Outcome Measure Information:
Title
CHEOPS score
Description
The Eastern Ontario Children's Hospital Pain Score (CHEOPS score) at the time of 2h and 6h after surgery
Time Frame
up to 6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: phimosis Exclusion Criteria: cardiopathy asthma dysgnosia surdimutism hepatopathy or nephropathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sun Ji Hong, bachelor
Organizational Affiliation
Yangzhou University
Official's Role
Study Chair
Facility Information:
Facility Name
Affiliated hospital of yangzhou university
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225100
Country
China

12. IPD Sharing Statement

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

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