PainNCT05811221
Application of Different Modes of Esketamine Administration in Pediatric Day Circumcision
A study testing Esketamine of single injection and Esketamine of Intermittent injection in people with Pain, run by Yangzhou University.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years, men only
- Conditions the study is for
- Pain
- What is being tested?
- Esketamine of single injection and Esketamine of Intermittent injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 2 Apr 2023to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Hepatic and renal insufficiency, coagulation dysfunction
- Those who are allergic to esketamine
- History of cognitive impairment
- epilepsy
- other psychiatric and neurological disorders
About this study
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.
Read the 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.
- Conditions
- Pain
- Being tested
- Esketamine of single injection, Esketamine of Intermittent injection
- Keywords
- Pediatric circumcision, Mode of administration, Day surgery, Esketamine
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esketamine of single injectionDrug
Also called A single injection of esketamine at the time of anesthesia induction
Single group: give esketamine 0.75 mg/kg at the time of induction
Esketamine of Intermittent injectionDrug
Also called A Intermittent injection of esketamine at the time of anesthesia induction
Intermittent group: give esketamine 0.5mg/kg during anesthesia induction, and during the measuring ring esketamine 0.25mg/kg was given again
| Study group | Role | What they receive |
|---|---|---|
| single group | Active comparator | give esketamine 0.75 mg/kg at the time of induction Receives: Drug: Esketamine of single injection |
| intermittent group | Experimental | give esketamine 0.5mg/kg during anesthesia induction, and during the measuring ring esketamine 0.25mg/kg was given again Receives: Drug: Esketamine of Intermittent injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
One-time success rate of anesthesia
No movement during anesthesia
Measured: During surgery
Secondary outcomes (9)
Systolic blood pressure
Systolic blood pressure
Measured: During surgery
Diastolic blood pressure
Diastolic blood pressure
Measured: During surgery
Heart rate
Heart rate
Measured: During surgery
intraoperative propofol dosage, esketamine dosage
intraoperative propofol dosage, esketamine dosage
Measured: During surgery
Duration of surgery
Duration of surgery
Measured: During surgery
Time to open eyes
Time to open eyes
Measured: During surgery
Time to talk
Time to talk
Measured: During surgery
VAS(visual analogue scale) score
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.
Measured: 12 hours after the end of surgery
Incidence of adverse effects (hypotension, hypertension, respiratory depression, postoperative pain, diplopia, mania)
Incidence of adverse effects (hypotension, hypertension, respiratory depression, postoperative pain, diplopia, mania)
Measured: 12 hours after the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start2 Apr 2023 (estimated)
- Primary completion15 May 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yangzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang wanxia, Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05811221
- Sponsor's protocol ID
- 2023-YKL01-（ke11）
- Status last verified
- Mar 2023
- First submitted
- 1 Mar 2023
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Different Modes of Esketamine Administration in Pediatric Day Circumcision
- ClinicalTrials.gov ID
- NCT05811221
- Acronym / sponsor ID
- 2023-YKL01-（ke11）
- Conditions
- Pain
- Keywords
- Pediatric circumcision, Mode of administration, Day surgery, Esketamine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Yangzhou UniversityUniversity, hospital or other
- Study start
- 2 Apr 2023 (estimated)
- Primary completion
- 15 May 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 13 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single group | Active comparator | Drug: Esketamine of single injectiongive esketamine 0.75 mg/kg at the time of induction |
| intermittent group | Experimental | Drug: Esketamine of Intermittent injectiongive esketamine 0.5mg/kg during anesthesia induction, and during the measuring ring esketamine 0.25mg/kg was given again |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Hepatic and renal insufficiency, coagulation dysfunction
- Those who are allergic to esketamine
- History of cognitive impairment
- epilepsy
- other psychiatric and neurological disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esketamine of single injectionAlso: A single injection of esketamine at the time of anesthesia inductionSingle group: give esketamine 0.75 mg/kg at the time of induction | Drug | single group |
| Esketamine of Intermittent injectionAlso: A Intermittent injection of esketamine at the time of anesthesia inductionIntermittent group: give esketamine 0.5mg/kg during anesthesia induction, and during the measuring ring esketamine 0.25mg/kg was given again | Drug | intermittent group |
Primary outcome
One-time success rate of anesthesia
Time frame: During surgery
No movement during anesthesia
9 secondary outcomes
Systolic blood pressure
Time frame: During surgery
Diastolic blood pressure
Time frame: During surgery
Heart rate
Time frame: During surgery
intraoperative propofol dosage, esketamine dosage
Time frame: During surgery
Duration of surgery
Time frame: During surgery
Time to open eyes
Time frame: During surgery
Time to talk
Time frame: During surgery
VAS(visual analogue scale) score
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Esketamine of single injection and Esketamine of Intermittent injection in people with Pain, run by Yangzhou University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One-time success rate of anesthesia (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.