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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
172
During anesthesia induction, a 0.2 mg/kg esketamine bolus was administered intravenously.
During anesthesia induction, a bolus of equal 0.9% saline was administered intravenously.
Fujian Provincial Hospital
Fuzhou, Fujian, China
RECRUITINGIncidence of postoperative negative behavior changes
Postoperative negative behavior changes were assessed with Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).
Time frame: Postoperative day 7
Incidence of postoperative negative behavior changes
Postoperative negative behavior changes were assessed with Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).
Time frame: Postoperative day 1
Incidence of emergence delirium
Emergence delirium was assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale (defined as a PAED score of ≥10).
Time frame: 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).
Time frame: Postoperative day 30
Postoperative pain intensity
Postoperative pain intensity will be measured using the face, legs, activity, cry, and consolability scale.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: Up to 24 hours postoperatively
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