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The goal of this clinical trial is to learn the effect of intravenous esketamine in postoperative negative behavior changes in children compared to placebo (a look-alike substance that contains no drug). It will also learn about the effect of esketamine in emergence delirium. The main questions are:
Dose esketamine lower the incidence of postoperative negative behavior changes compared to placebo? Dose esketamine lower the incidence of emergence delirium compared to placebo? Researchers will compare esketamine to placebo to see if esketamine works to treat postoperative negative behavior change and emergence delirium.
Participants will:
Receive intravenous esketamine or placebo (a look-alike substance that contains no drug) during anesthesia induction; Fill in the Post hospitalization behavior questionnaire for ambulatory surgery postoperative 1, 7, and 30
Approximately half of children who undergo general anesthesia experience emergence delirium (ED) and postoperative negative behavioral changes (PNBC). There was a positive correlation between delirium during recovery and the change in negative behaviour after the operation.
Esketamine has sedative, analgesic and anti-traumatic stress effects. Based on literature analysis and preliminary trials, this study suggests that intraoperative use of low-dose esketamine may reduce the incidence of emergence delirium and postoperative negative behavior changes in children.
This prospective randomized controlled trial was conducted to compare the effect of intravenous esketamine in the incidence of emergence delirium and postoperative negative behavior changes in children compared to placebo (a look-alike substance that contains no drug) to provide a reference for optimizing clinical anesthesia medication regimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esketamine group | Experimental | During anesthesia induction, 0.2 mg/kg esketamine was administered intravenously. |
|
| Control group | Placebo Comparator | During anesthesia induction, an equal volume of 0.9% saline was administered intravenously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esketamine hydrochloride | Drug | During anesthesia induction, a 0.2 mg/kg esketamine bolus was administered intravenously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative negative behavior changes | Postoperative negative behavior changes were assessed with Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS). | Postoperative day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative negative behavior changes | Postoperative negative behavior changes were assessed with Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS). | Postoperative day 1 |
| Incidence of emergence delirium |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yusheng Yao, MD&PhD | Contact | 13559939629 | fjslyys@fjmu.edu.cn | |
| Sisi Chen, MD | Contact | 15080109541 | chensisi49@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaochun Zheng, MD | Fujian Provincial Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Provincial Hospital | Recruiting | Fuzhou | Fujian | 350001 | China |
After publication, the individual deidentified participant data underlying published results, the study protocol, and the statistical analysis plan can be accessed upon reasonable request from the corresponding author.
The researcher would like to share the individual deidentified participant data beginning three months following the publication of the main results.
All the individual participant data collected during the trial, the study protocol, the statistical analysis plan, and the clinical study report can be accessed with approval from the corresponding author.
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| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| normal saline | Drug | During anesthesia induction, a bolus of equal 0.9% saline was administered intravenously. |
|
Emergence delirium was assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale (defined as a PAED score of ≥10).
| Within 30 minutes after extubation |
| Incidence of postoperative negative behavior changes | Postoperative negative behavior changes were assessed with Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS). | Postoperative day 30 |
| Postoperative pain intensity | Postoperative pain intensity will be measured using the face, legs, activity, cry, and consolability scale. | Within 30 minutes after extubation |
| Preoperative anxiety | Preoperative anxiety will be assessed using the modified Yale preoperative anxiety scale. Scores range from 23 to 100 with higher scores indicating greater anxiety. | Before the intervention in holding area |
| Emergence time | Emergence time is defined as the interval from discontinuation of inhalation anesthetic to eye-opening on verbal command. | About up to 30 minutes postoperatively |
| Parental satisfaction | Parental satisfaction is self-reported using a five-point Likert scale (5=very satisfied, 4=satisfied, 3=neither satisfied nor dissatisfied, 2=dissatisfied, and 1=very dissatisfied). | Postoperative day 1 |
| Length of postanesthesia care unit stay | Length of postanesthesia care unit (PACU) stay is defined as the time between arrival in the PACU and readiness for discharge from the PACU (defined as a modified Aldrete score of ≥9). | Up to 60 minutes postoperatively |
| Incidence of adverse events | Adverse events such as bradycardia, tachycardia, hypertension, hypotension, and hypoxia will be recorded during the trial. | Up to 24 hours postoperatively |
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |