Behavior Problem
Conditions
Keywords
esketamine, postoperative negative behavioral change, pediatrics, emergence delirium, tonsillectomy, adenoidectomy
Brief summary
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
During anesthesia induction, a 0.2 mg/kg esketamine bolus was administered intravenously.
DRUGnormal saline
During anesthesia induction, a bolus of equal 0.9% saline was administered intravenously.
Sponsors
Fujian Provincial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 7 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative negative behavior changes | Postoperative day 7 | Postoperative negative behavior changes were assessed with Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of emergence delirium | Within 30 minutes after extubation | Emergence delirium was assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale (defined as a PAED score of ≥10). |
| Postoperative pain intensity | Within 30 minutes after extubation | Postoperative pain intensity will be measured using the face, legs, activity, cry, and consolability scale. |
| Preoperative anxiety | Before the intervention in holding area | Preoperative anxiety will be assessed using the modified Yale preoperative anxiety scale. Scores range from 23 to 100 with higher scores indicating greater anxiety. |
| Incidence of postoperative negative behavior changes | Postoperative day 1 | Postoperative negative behavior changes were assessed with Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS). |
| Parental satisfaction | Postoperative day 1 | 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). |
| Length of postanesthesia care unit stay | Up to 60 minutes postoperatively | 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). |
| Incidence of adverse events | Up to 24 hours postoperatively | Adverse events such as bradycardia, tachycardia, hypertension, hypotension, and hypoxia will be recorded during the trial. |
| Emergence time | About up to 30 minutes postoperatively | Emergence time is defined as the interval from discontinuation of inhalation anesthetic to eye-opening on verbal command. |
Countries
China
Contacts
Primary ContactYusheng Yao, MD&PhD
Backup ContactSisi Chen, MD
Outcome results
None listed