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

NCT06579937 | Recruiting Phase 4 DMC

• 1 other identifier: K2023-02-005
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

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

Conditions

Behavior Problem

Keywords

esketamine; postoperative negative behavioral change; pediatrics; emergence delirium; tonsillectomy; adenoidectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Incidence of postoperative negative behavior changes

  Postoperative day 1

• Incidence of emergence delirium

  Within 30 minutes after extubation

• Incidence of postoperative negative behavior changes

  Postoperative day 30

• Postoperative pain intensity

  Within 30 minutes after extubation

• Preoperative anxiety

  Before the intervention in holding area

Study Arms (2)

Esketamine group

EXPERIMENTAL

During anesthesia induction, 0.2 mg/kg esketamine was administered intravenously.

Drug: Esketamine hydrochloride

Control group

PLACEBO COMPARATOR

During anesthesia induction, an equal volume of 0.9% saline was administered intravenously.

Drug: normal saline

Interventions

Esketamine hydrochloride DRUG

During anesthesia induction, a 0.2 mg/kg esketamine bolus was administered intravenously.

Also known as: esketamine hydrochloride injection

Esketamine group

normal saline DRUG

During anesthesia induction, a bolus of equal 0.9% saline was administered intravenously.

Control group

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• American society of Aneshesiologists physical status I or II;
• Aged 3-7 years;
• Scheduled for elective tonsillectomy and (or) adenoidectomy.

You may not qualify if:

• 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.;

Sponsors & Collaborators

• Fujian Provincial Hospital: lead

Study Sites (1)

Fujian Provincial Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

MeSH Terms

Conditions

Mental Disorders; Emergence Delirium

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Xiaochun Zheng, MD

  Fujian Provincial Hospital

  STUDY CHAIR

Central Study Contacts

Yusheng Yao, MD&PhD

CONTACT

13559939629; fjslyys@fjmu.edu.cn

Sisi Chen, MD

CONTACT

15080109541; chensisi49@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: August 30, 2024
• Study Start: September 2, 2024
• Primary Completion: September 30, 2025
• Study Completion: October 30, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The researcher would like to share the individual deidentified participant data beginning three months following the publication of the main results.
• 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.

Locations

CN (1)