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

The Best Dose of Esketamine for Day Surgery of Pediatric Circumcision

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.

Study Overview

• Status: Completed
• Conditions: Phimosis
• Intervention / Treatment: Drug: Esketamine

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: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Yangzhou, Jiangsu, China, 225100
      • Affiliated Hospital of Yangzhou University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• phimosis

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
recovery time	the time from stopping sevoflurane to resuscitation	up to 2 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CHEOPS score	The Eastern Ontario Children's Hospital Pain Score (CHEOPS score) at the time of 2h and 6h after surgery	up to 6 hours

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Actual): February 20, 2021
• Study Completion (Actual): March 30, 2021

Study Registration Dates

• First Submitted: July 31, 2020
• First Submitted That Met QC Criteria: January 5, 2021
• First Posted (Actual): January 6, 2021

Study Record Updates

• Last Update Posted (Actual): February 10, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Children; Sevoflurane; Esketamine; circumcise
• Additional Relevant MeSH Terms: Penile Diseases; Phimosis; Psychotropic Drugs; Antidepressive Agents; Esketamine
• Other Study ID Numbers: Y015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No