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

Sponsor
Yangzhou University (Other)
Overall Status
Completed
CT.gov ID
NCT04698434
Collaborator
(none)
90
1
3
2.4
37

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
90 participants
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.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
Official Title:
The Best Dose of Esketamine for Day Surgery of Pediatric Circumcision
Actual Study Start Date :
Jan 15, 2021
Actual Primary Completion Date :
Feb 20, 2021
Actual Study Completion Date :
Mar 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 0.5mg/kg esketamine group

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

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

Active Comparator: .75mg/kg esketamine group

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

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

Active Comparator: 1.0mg/kg esketamine group

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

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

Outcome Measures

Primary Outcome Measures

  1. recovery time [up to 2 hour]

    the time from stopping sevoflurane to resuscitation

Secondary Outcome Measures

  1. CHEOPS score [up to 6 hours]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • phimosis
Exclusion Criteria:
  • cardiopathy

  • asthma

  • dysgnosia

  • surdimutism

  • hepatopathy or nephropathy

Contacts and Locations

Locations

Site City State Country Postal Code
1 Affiliated hospital of yangzhou university Yangzhou Jiangsu China 225100

Sponsors and Collaborators

  • Yangzhou University

Investigators

  • Study Chair: Sun Ji Hong, bachelor, Yangzhou University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ma Hong, Principal Investigator, Yangzhou University
ClinicalTrials.gov Identifier:
NCT04698434
Other Study ID Numbers:
  • Y015
First Posted:
Jan 6, 2021
Last Update Posted:
Feb 10, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ma Hong, Principal Investigator, Yangzhou University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 10, 2022