Skip to content

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

The Best Dose of Esketamine for Day Surgery of Pediatric Circumcision

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04698434
Enrollment
90
Registered
2021-01-06
Start date
2021-01-15
Completion date
2021-03-30
Last updated
2022-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Phimosis

Keywords

Esketamine, Sevoflurane, Children, circumcise

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.

Interventions

DRUGEsketamine

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

Sponsors

Yangzhou University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

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.

Eligibility

Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

* phimosis

Exclusion criteria

* cardiopathy * asthma * dysgnosia * surdimutism * hepatopathy or nephropathy

Design outcomes

Primary

MeasureTime frameDescription
recovery timeup to 2 hourthe time from stopping sevoflurane to resuscitation

Secondary

MeasureTime frameDescription
CHEOPS scoreup to 6 hoursThe Eastern Ontario Children's Hospital Pain Score (CHEOPS score) at the time of 2h and 6h after surgery

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026