Effects of Esketamine on Postoperative Behavioral Changes in Children Undergoing Tonsillectomy and/or Adenoidectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Esketamine hydrochloride, normal saline.
- Who it may be relevant to
- Registry conditions: Behavior Problem. Basic parameters: 3 years — 7 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Esketamine for the Prevention of Postoperative Behavioral Changes in Children Undergoing Tonsillectomy and/or Adenoidectomy: a Randomized Controlled Trial
Overview
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
Detailed description
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.
Interventions
- Drug Esketamine hydrochloride
During anesthesia induction, a 0.2 mg/kg esketamine bolus was administered intravenously. - Drug normal saline
During anesthesia induction, a bolus of equal 0.9% saline was administered intravenously.
Primary outcome measures
- Incidence of postoperative negative behavior changes [Time frame: Postoperative day 7]
Secondary outcome measures (9)
- Incidence of postoperative negative behavior changes [Time frame: Postoperative day 1]
- Incidence of emergence delirium [Time frame: Within 30 minutes after extubation]
- Incidence of postoperative negative behavior changes [Time frame: Postoperative day 30]
- Postoperative pain intensity [Time frame: Within 30 minutes after extubation]
- Preoperative anxiety [Time frame: Before the intervention in holding area]
- Emergence time [Time frame: About up to 30 minutes postoperatively]
- Parental satisfaction [Time frame: Postoperative day 1]
- Length of postanesthesia care unit stay [Time frame: Up to 60 minutes postoperatively]
- Incidence of adverse events [Time frame: Up to 24 hours postoperatively]
Eligibility criteria
Inclusion criteria
- American society of Aneshesiologists physical status I or II;
- Aged 3-7 years;
- Scheduled for elective tonsillectomy and (or) adenoidectomy.
Exclusion criteria
- Parents refusing to allow their children to participate;
- Intake of sedative or analgesic medication within 48 hours before surgery;
- Developmental delay;
- Psychosis;
- Body mass index > 30 kg/m2;
- Allergy to study drugs;
- Major life changes 1 month before the operation, such as the divorce of parents, death of parents, moving to a new home, changing to a new kindergarten, etc.;
- Any other conditions that precluded study inclusion.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Fujian Provincial Hospital — Fuzhou
Identifiers
NCT: NCT06579937 · K2023-02-005