Effects of Esketamine at Subanesthetic Dose on Emergence Delirium in Preschool Children Undergoing Ambulatory Laparoscopic Surgery

Emergence delirium (ED) is a manifestation of acute postoperative brain dysfunction that occurs with a relatively high frequency after pediatric anesthesia. The incidence varies depending on the diagnostic criteria used and the combination of administered anesthetic drugs. The goal of this clinical trial is to investigate whether a subanesthetic dose of esketamine can reduce incidence of ED.

Study Overview

• Status: Completed
• Conditions: Inguinal Hernia
• Intervention / Treatment: Drug: 0.1mg/kg esketamine; Drug: 0.2mg/kg esketamine; Drug: 0.1ml/kg normal saline

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310052
      • The Children's Hospital, Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. laparoscopic inguinal hernia repair under general anesthesia
2. aged 24~71 months
3. American Society of Anesthesiologists Physical Status I or II
4. body mass index for age between the 5th and 85th percentiles

Exclusion Criteria:

1. allergy to esketamine
2. abnormal liver or kidney function
3. glaucoma or neurological disorders
4. cardiovascular or endocrine dysfunction
5. asthma or respiratory infection in the last 2 weeks
6. developmental delay

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group S1 (0.1mg/kg esketamine)	Drug: 0.1mg/kg esketamine; Intravenous injection 0.1mg/kg esketamine about 5min before the end of the surgery
Experimental: group S2 (0.2mg/kg esketamine)	Drug: 0.2mg/kg esketamine; Intravenous injection 0.2mg/kg esketamine about 5min before the end of the surgery
Placebo Comparator: group C (0.1ml/kg Normal saline)	Drug: 0.1ml/kg normal saline; Intravenous injection 0.1ml/kg normal saline about 5min before the end of the surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of emergence delirium	The pediatric anesthesia emergence delirium scale consists of four items. Each item is scored 0-4 yielding a total between 0 and 20. The degree of emergence delirium increased directly with the total score. Pediatric anesthesia emergence delirium scores ≥10 at any time indicates presence of emergence delirium.	Within up to 30 minutes after emergence from anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tracheal catheter extubation time	The time from the cessation of sevoflurane to the point when the tracheal catheter would be remove.	Within up to 30 minutes after operation
emergence from anesthesia time	The time from the cessation of sevoflurane to the point when the child would respond to sound stimuli or open their eyes.	Within up to 30 minutes after operation
The incidence of postoperative pain	The FLACC scale consists of five items. Each item is scored 0-2 yielding a total between 0 and 10. The degree of pain increased directly with the total score. FLACC scores 4 or greater indicates presence of emergence delirium.	Within up to 30 minutes after operation
Recovery time	The time from the cessation of sevoflurane to the point when the child was awakened and responded readily to their name spoken in a normal tone of voice.	Within up to 50 minutes after operation
The incidence of adverse effects	Postoperative nausea, vomiting, salivation, bradycardia, hypotension, and respiratory depression within 24 hours after surgery.	24 hours after surgery.
Blood pressure	Blood pressure of children were measured at 0min, 5min, 10min and 20min after injection of study drug or normal saline.	Intraoperative and up to postoperative 20 minutes
heart rate	heart rate of children were measured at 0min, 5min, 10min and 20min after injection of study drug or normal saline.	Intraoperative and up to postoperative 20 minutes

Collaborators and Investigators

• Sponsor: Qiu jinpeng

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2025
• Primary Completion (Actual): May 16, 2025
• Study Completion (Actual): May 16, 2025

Study Registration Dates

• First Submitted: January 17, 2025
• First Submitted That Met QC Criteria: January 22, 2025
• First Posted (Actual): January 23, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2025
• Last Update Submitted That Met QC Criteria: May 18, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Pathological Conditions, Anatomical; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Hernia; Hernia, Abdominal; Emergence Delirium; Delirium; Hernia, Inguinal; Psychotropic Drugs; Antidepressive Agents; Esketamine
• Other Study ID Numbers: 2024-IRB-0377-P-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No