Application of Different Modes of Esketamine Administration in Pediatric Day Circumcision

March 30, 2023 updated by: Wang wanxia, Yangzhou University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
One-time success rate of anesthesia
Time Frame: During surgery
No movement during anesthesia
During surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic blood pressure
Time Frame: During surgery
Systolic blood pressure
During surgery
Diastolic blood pressure
Time Frame: During surgery
Diastolic blood pressure
During surgery
Heart rate
Time Frame: During surgery
Heart rate
During surgery
intraoperative propofol dosage, esketamine dosage
Time Frame: During surgery
intraoperative propofol dosage, esketamine dosage
During surgery
Duration of surgery
Time Frame: During surgery
Duration of surgery
During surgery
Time to open eyes
Time Frame: During surgery
Time to open eyes
During surgery
Time to talk
Time Frame: During surgery
Time to talk
During surgery
VAS(visual analogue scale) score
Time Frame: 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.
12 hours after the end of surgery
Incidence of adverse effects (hypotension, hypertension, respiratory depression, postoperative pain, diplopia, mania)
Time Frame: 12 hours after the end of surgery
Incidence of adverse effects (hypotension, hypertension, respiratory depression, postoperative pain, diplopia, mania)
12 hours after the end of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yangzhou University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 2, 2023

Primary Completion (Anticipated)

May 15, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

March 1, 2023

First Submitted That Met QC Criteria

March 30, 2023

First Posted (Actual)

April 13, 2023

Study Record Updates

Last Update Posted (Actual)

April 13, 2023

Last Update Submitted That Met QC Criteria

March 30, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-YKL01-（ke11）

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe