Inguinal HerniaNCT06789185
Effects of Esketamine at Subanesthetic Dose on Emergence Delirium in Preschool Children Undergoing Ambulatory Laparoscopic Surgery
A study testing 0.1mg/kg esketamine, 0.2mg/kg esketamine and 0.1ml/kg normal saline in people with Inguinal Hernia, run by Qiu jinpeng at 1 site in China.
Trial summary
Emergence delirium (ED) is a manifestation of acute postoperative brain dysfunction that occurs with a relatively high frequency after pediatric anesthesia. The incidence varies depending on the diagnostic criteria used and the combination of administered anesthetic drugs. Read more about this study
- Who is it for?
- Ages 24 to 71 months
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- 0.1mg/kg esketamine, 0.2mg/kg esketamine and 0.1ml/kg normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 7 Feb 2025to 16 May 2025
- 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 24 to 71 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- laparoscopic inguinal hernia repair under general anesthesia
- aged 24~71 months
- American Society of Anesthesiologists Physical Status I or II
- body mass index for age between the 5th and 85th percentiles
Who cannot join
- allergy to esketamine
- abnormal liver or kidney function
- glaucoma or neurological disorders
- cardiovascular or endocrine dysfunction
- asthma or respiratory infection in the last 2 weeks
- developmental delay
Trial locations and contacts
1 site in 1 country.
China1 site
The Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310052
About this study
Emergence delirium (ED) is a manifestation of acute postoperative brain dysfunction that occurs with a relatively high frequency after pediatric anesthesia. The incidence varies depending on the diagnostic criteria used and the combination of administered anesthetic drugs. The goal of this clinical trial is to investigate whether a subanesthetic dose of esketamine can reduce incidence of ED.
- Conditions
- Inguinal Hernia
- Being tested
- 0.1mg/kg esketamine, 0.2mg/kg esketamine, 0.1ml/kg normal saline
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.1mg/kg esketamineDrug
Intravenous injection 0.1mg/kg esketamine about 5min before the end of the surgery
0.2mg/kg esketamineDrug
Intravenous injection 0.2mg/kg esketamine about 5min before the end of the surgery
0.1ml/kg normal salineDrug
Intravenous injection 0.1ml/kg normal saline about 5min before the end of the surgery
| Study group | Role | What they receive |
|---|---|---|
| group S1 (0.1mg/kg esketamine) | Experimental | Not described Receives: Drug: 0.1mg/kg esketamine |
| group S2 (0.2mg/kg esketamine) | Experimental | Not described Receives: Drug: 0.2mg/kg esketamine |
| group C (0.1ml/kg Normal saline) | Placebo comparator | Not described Receives: Drug: 0.1ml/kg normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of emergence delirium
The pediatric anesthesia emergence delirium scale consists of four items. Each item is scored 0-4 yielding a total between 0 and 20. The degree of emergence delirium increased directly with the total score. Pediatric anesthesia emergence delirium scores ≥10 at any time indicates presence of emergence delirium.
Measured: Within up to 30 minutes after emergence from anesthesia
Secondary outcomes (7)
Tracheal catheter extubation time
The time from the cessation of sevoflurane to the point when the tracheal catheter would be remove.
Measured: Within up to 30 minutes after operation
emergence from anesthesia time
The time from the cessation of sevoflurane to the point when the child would respond to sound stimuli or open their eyes.
Measured: Within up to 30 minutes after operation
The incidence of postoperative pain
The FLACC scale consists of five items. Each item is scored 0-2 yielding a total between 0 and 10. The degree of pain increased directly with the total score. FLACC scores 4 or greater indicates presence of emergence delirium.
Measured: Within up to 30 minutes after operation
Recovery time
The time from the cessation of sevoflurane to the point when the child was awakened and responded readily to their name spoken in a normal tone of voice.
Measured: Within up to 50 minutes after operation
The incidence of adverse effects
Postoperative nausea, vomiting, salivation, bradycardia, hypotension, and respiratory depression within 24 hours after surgery.
Measured: 24 hours after surgery.
Blood pressure
Blood pressure of children were measured at 0min, 5min, 10min and 20min after injection of study drug or normal saline.
Measured: Intraoperative and up to postoperative 20 minutes
heart rate
heart rate of children were measured at 0min, 5min, 10min and 20min after injection of study drug or normal saline.
Measured: Intraoperative and up to postoperative 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start7 Feb 2025
- Primary completion16 May 2025
- Study completion16 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qiu jinpeng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qiu jinpeng, The Children's Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789185
- Sponsor's protocol ID
- 2024-IRB-0377-P-01
- Status last verified
- May 2025
- First submitted
- 17 Jan 2025
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Esketamine at Subanesthetic Dose on Emergence Delirium in Preschool Children Undergoing Ambulatory Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT06789185
- Acronym / sponsor ID
- 2024-IRB-0377-P-01
- Conditions
- Inguinal Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Qiu jinpengUniversity, hospital or other
- Study start
- 7 Feb 2025 (actual)
- Primary completion
- 16 May 2025 (actual)
- Study completion
- 16 May 2025 (actual)
- First posted
- 23 Jan 2025 (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.
Emergence delirium (ED) is a manifestation of acute postoperative brain dysfunction that occurs with a relatively high frequency after pediatric anesthesia. The incidence varies depending on the diagnostic criteria used and the combination of administered anesthetic drugs. The goal of this clinical trial is to investigate whether a subanesthetic dose of esketamine can reduce incidence of ED.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group S1 (0.1mg/kg esketamine) | Experimental | Drug: 0.1mg/kg esketamine |
| group S2 (0.2mg/kg esketamine) | Experimental | Drug: 0.2mg/kg esketamine |
| group C (0.1ml/kg Normal saline) | Placebo comparator | Drug: 0.1ml/kg normal saline |
Who may qualify
- Ages
- 24 to 71 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- laparoscopic inguinal hernia repair under general anesthesia
- aged 24~71 months
- American Society of Anesthesiologists Physical Status I or II
- body mass index for age between the 5th and 85th percentiles
Key exclusion criteria (6 listed)
- allergy to esketamine
- abnormal liver or kidney function
- glaucoma or neurological disorders
- cardiovascular or endocrine dysfunction
- asthma or respiratory infection in the last 2 weeks
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 |
|---|---|---|
| 0.1mg/kg esketamineIntravenous injection 0.1mg/kg esketamine about 5min before the end of the surgery | Drug | group S1 (0.1mg/kg esketamine) |
| 0.2mg/kg esketamineIntravenous injection 0.2mg/kg esketamine about 5min before the end of the surgery | Drug | group S2 (0.2mg/kg esketamine) |
| 0.1ml/kg normal salineIntravenous injection 0.1ml/kg normal saline about 5min before the end of the surgery | Drug | group C (0.1ml/kg Normal saline) |
Primary outcome
The incidence of emergence delirium
Time frame: Within up to 30 minutes after emergence from anesthesia
The pediatric anesthesia emergence delirium scale consists of four items. Each item is scored 0-4 yielding a total between 0 and 20. The degree of emergence delirium increased directly with the total score. Pediatric anesthesia emergence delirium scores ≥10 at any time indicates presence of emergence delirium.
7 secondary outcomes
Tracheal catheter extubation time
Time frame: Within up to 30 minutes after operation
emergence from anesthesia time
Time frame: Within up to 30 minutes after operation
The incidence of postoperative pain
Time frame: Within up to 30 minutes after operation
Recovery time
Time frame: Within up to 50 minutes after operation
The incidence of adverse effects
Time frame: 24 hours after surgery.
Blood pressure
Time frame: Intraoperative and up to postoperative 20 minutes
heart rate
Time frame: Intraoperative and up to postoperative 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.1mg/kg esketamine, 0.2mg/kg esketamine and 0.1ml/kg normal saline in people with Inguinal Hernia, run by Qiu jinpeng at 1 site in China.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The incidence of emergence delirium (time frame: Within up to 30 minutes after emergence from anesthesia). 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 22 May 2025.