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

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ClinicalTrials.gov Identifier: NCT04698434
Recruitment Status : Recruiting
First Posted : January 6, 2021
Last Update Posted : January 6, 2021
Sponsor:
Information provided by (Responsible Party):
Ma Hong, Yangzhou University

Tracking Information
First Submitted Date  ICMJE July 31, 2020
First Posted Date  ICMJE January 6, 2021
Last Update Posted Date January 6, 2021
Estimated Study Start Date  ICMJE January 15, 2021
Estimated Primary Completion Date February 20, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2021)
recovery time [ Time Frame: up to 2 hour ]
the time from stopping sevoflurane to resuscitation
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2021)
CHEOPS score [ Time Frame: up to 6 hours ]
The Eastern Ontario Children's Hospital Pain Score (CHEOPS score) at the time of 2h and 6h after surgery
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Best Dose of Esketamine for Day Surgery of Pediatric Circumcision Pediatric Circumcision
Official Title  ICMJE The Best Dose of Esketamine for Day Surgery of Pediatric Circumcision
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Phimosis
Intervention  ICMJE Drug: Esketamine
each group was given a single intravenous dose of the corresponding esketamine.
Study Arms  ICMJE
  • Active Comparator: 0.5mg/kg esketamine group
    0.5mg/kg esketamine group will be given a single intravenous 0.5mg/kg esketamine
    Intervention: Drug: Esketamine
  • Active Comparator: .75mg/kg esketamine group
    0.75mg/kg esketamine groupwill be given a single intravenous 0.75mg/kg esketamine
    Intervention: Drug: Esketamine
  • Active Comparator: 1.0mg/kg esketamine group
    1.0mg/kg esketamine group will be given a single intravenous 1.5mg/kg esketamine
    Intervention: Drug: Esketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 5, 2021)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 30, 2021
Estimated Primary Completion Date February 20, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • phimosis

Exclusion Criteria:

  • cardiopathy
  • asthma
  • dysgnosia
  • surdimutism
  • hepatopathy or nephropathy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: MA HONG, bachelor 13675161040 mahongyzdaxue@163.com
Contact: LIU Me YU, MASTER 17761980727 myliu@yzu.edu.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04698434
Other Study ID Numbers  ICMJE Y015
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ma Hong, Yangzhou University
Study Sponsor  ICMJE Yangzhou University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Sun Ji Hong, bachelor Yangzhou University
PRS Account Yangzhou University
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP