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

Esketamine for the Prevention of Postoperative Behavioral Changes in Children Undergoing Tonsillectomy and/or Adenoidectomy: a Randomized Controlled Trial

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

Study Overview

• Status: Recruiting
• Conditions: Behavior Problem
• Intervention / Treatment: Drug: Esketamine hydrochloride; Drug: normal saline

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 Type: Interventional
• Enrollment (Estimated): 172
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yusheng Yao, MD&PhD; Phone Number: 13559939629; Email: fjslyys@fjmu.edu.cn
• Study Contact Backup: Name: Sisi Chen, MD; Phone Number: 15080109541; Email: chensisi49@163.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Recruiting
      • Fujian Provincial Hospital
      • Contact: Sisi Chen, MD; Phone Number: 15080109541; Email: chensisi49@163.com
      • Contact: Yusheng Yao, MD&PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Esketamine group; During anesthesia induction, 0.2 mg/kg esketamine was administered intravenously.	Drug: Esketamine hydrochloride; During anesthesia induction, a 0.2 mg/kg esketamine bolus was administered intravenously.; Other Names: esketamine hydrochloride injection
Placebo Comparator: Control group; During anesthesia induction, an equal volume of 0.9% saline was administered intravenously.	Drug: normal saline; During anesthesia induction, a bolus of equal 0.9% saline was administered intravenously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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	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
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

Collaborators and Investigators

• Sponsor: Fujian Provincial Hospital
• Investigators: Study Chair: Xiaochun Zheng, MD, Fujian Provincial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2024
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): October 30, 2025

Study Registration Dates

• First Submitted: August 29, 2024
• First Submitted That Met QC Criteria: August 29, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 27, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: pediatrics; esketamine; tonsillectomy; emergence delirium; adenoidectomy; postoperative negative behavioral change
• Additional Relevant MeSH Terms: Behavioral Symptoms; Problem Behavior; Psychotropic Drugs; Antidepressive Agents; Esketamine
• Other Study ID Numbers: K2023-02-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: The researcher would like to share the individual deidentified participant data beginning three months following the publication of the main results.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No