NCT06579937

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 172 (estimated)
• Sponsor: Fujian Provincial Hospital · Academic / Other
• Sex: All
• Age: 3 Years – 7 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Behavior Problem

Interventions

Type	Name	Description
DRUG	Esketamine hydrochloride	During anesthesia induction, a 0.2 mg/kg esketamine bolus was administered intravenously.
DRUG	normal saline	During anesthesia induction, a bolus of equal 0.9% saline was administered intravenously.

Timeline

• Start date: 2024-09-02
• Primary completion: 2025-09-30
• Completion: 2025-10-30
• First posted: 2024-08-30
• Last updated: 2024-10-01

Locations

1 site across 1 country: China