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Application of Different Modes of Esketamine Administration in Pediatric Day Circumcision

Sponsor
Yangzhou University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05811221
Collaborator
(none)
70
Enrollment
2
Arms
2
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Esketamine of single injection
  • Drug: Esketamine of Intermittent injection
 N/A

Detailed Description

The current clinical study believes that esketamine is suitable for pediatric anesthesia because of its advantages of light respiratory depression, low secretions, low incidence of psychomotor reactions and fast recovery of anesthesia, but there are few related studies on its administration mode and timing in clinical application, this study aims to explore the application of different administration methods of esketamine in pediatric day circumcision, and find an anesthesia scheme more suitable for day circumcision, in order to provide new ideas for anesthesia for pediatric day circumcision.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Application of Different Modes of Esketamine Administration in Pediatric Day Circumcision
Anticipated Study Start Date :
Apr 2, 2023
Anticipated Primary Completion Date :
May 15, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: single group

give esketamine 0.75 mg/kg at the time of induction

Drug: Esketamine of single injection
Single group: give esketamine 0.75 mg/kg at the time of induction
Other Names:
  • A single injection of esketamine at the time of anesthesia induction

    		•
    Experimental: intermittent group

    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
    Intermittent group: give esketamine 0.5mg/kg during anesthesia induction, and during the measuring ring esketamine 0.25mg/kg was given again
    Other Names:
  • A Intermittent injection of esketamine at the time of anesthesia induction

    		•

    Outcome Measures

    Primary Outcome Measures

    1. One-time success rate of anesthesia [During surgery]

      No movement during anesthesia

    Secondary Outcome Measures

    1. Systolic blood pressure [During surgery]

      Systolic blood pressure

    2. Diastolic blood pressure [During surgery]

      Diastolic blood pressure

    3. Heart rate [During surgery]

      Heart rate

    4. intraoperative propofol dosage, esketamine dosage [During surgery]

      intraoperative propofol dosage, esketamine dosage

    5. Duration of surgery [During surgery]

      Duration of surgery

    6. Time to open eyes [During surgery]

      Time to open eyes

    7. Time to talk [During surgery]

      Time to talk

    8. VAS(visual analogue scale) score [12 hours after the end of surgery]

      A score to assess pain, use a swimming ruler about 10 cm long, marked with 10 scales on one side, with "0" and "10" ends at each end, 0 points means no pain, and 10 points represent the most severe pain that is unbearable.

    9. Incidence of adverse effects (hypotension, hypertension, respiratory depression, postoperative pain, diplopia, mania) [12 hours after the end of surgery]

      Incidence of adverse effects (hypotension, hypertension, respiratory depression, postoperative pain, diplopia, mania)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 12 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • Hepatic and renal insufficiency, coagulation dysfunction

    • Those who are allergic to esketamine

    • History of cognitive impairment

    • epilepsy

    • other psychiatric and neurological disorders

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Yangzhou University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wang wanxia, Principal Investigator, Yangzhou University
    ClinicalTrials.gov Identifier:
    NCT05811221
    Other Study ID Numbers:
    • 2023-YKL01-（ke11）
    First Posted:
    Apr 13, 2023
    Last Update Posted:
    Apr 13, 2023
    Last Verified:
    Mar 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Wang wanxia, Principal Investigator, Yangzhou University
    Pediatric circumcision
    Mode of administration
    Day surgery
    Esketamine
    Additional relevant MeSH terms:
    Anesthetics
    Esketamine

    Study Results

    No Results Posted as of Apr 13, 2023