Effects of Esketamine on Postoperative Behavioral Changes in Children Undergoing Tonsillectomy and/or Adenoidectomy

Phase 4

Recruiting

• Conditions: Behavior Problem
• Interventions: Drug: Esketamine hydrochloride; Drug: normal saline

• Registration Number: NCT06579937
• Lead Sponsor: Fujian Provincial Hospital

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.

Study Timeline

• Study First Submitted: 2024-08-29
• Study First Submitted QC: 2024-08-29
• Study First Posted: 2024-08-30
• Status Verified: 2024-09
• Study Start: 2024-09-02
• Last Update Submitted: 2024-09-27
• Last Update Posted: 2024-10-01
• Primary Completion: 2025-09-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 172

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Esketamine group	Esketamine hydrochloride	During anesthesia induction, 0.2 mg/kg esketamine was administered intravenously.
Control group	normal saline	During anesthesia induction, an equal volume of 0.9% saline was administered intravenously.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Incidence of postoperative negative behavior changes	Postoperative day 30	Postoperative negative behavior changes were assessed with Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).
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.
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.
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.

Trial Locations

Locations (1)

Fujian Provincial Hospital; 🇨🇳 Fuzhou, Fujian, China