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

Not Applicable

Completed

• Conditions: Inguinal Hernia
• Interventions: Drug: 0.1mg/kg esketamine; Drug: 0.2mg/kg esketamine; Drug: 0.1ml/kg normal saline

• Registration Number: NCT06789185
• Lead Sponsor: Qiu jinpeng

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-17
• Study First Submitted QC: 2025-01-22
• Study First Posted: 2025-01-23
• Study Start: 2025-02-07
• Status Verified: 2025-05
• Primary Completion: 2025-05-16
• Study Completion: 2025-05-16
• Last Update Submitted: 2025-05-18
• Last Update Posted: 2025-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group S1 (0.1mg/kg esketamine)	0.1mg/kg esketamine	-
group S2 (0.2mg/kg esketamine)	0.2mg/kg esketamine	-
group C (0.1ml/kg Normal saline)	0.1ml/kg normal saline	-

Primary Outcome Measures

Name	Time	Method
The incidence of emergence delirium	Within up to 30 minutes after emergence from anesthesia	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.

Secondary Outcome Measures

Name	Time	Method
Tracheal catheter extubation time	Within up to 30 minutes after operation	The time from the cessation of sevoflurane to the point when the tracheal catheter would be remove.
emergence from anesthesia time	Within up to 30 minutes after operation	The time from the cessation of sevoflurane to the point when the child would respond to sound stimuli or open their eyes.
The incidence of postoperative pain	Within up to 30 minutes after operation	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.
Recovery time	Within up to 50 minutes after operation	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.
The incidence of adverse effects	24 hours after surgery.	Postoperative nausea, vomiting, salivation, bradycardia, hypotension, and respiratory depression within 24 hours after surgery.
Blood pressure	Intraoperative and up to postoperative 20 minutes	Blood pressure of children were measured at 0min, 5min, 10min and 20min after injection of study drug or normal saline.
heart rate	Intraoperative and up to postoperative 20 minutes	heart rate of children were measured at 0min, 5min, 10min and 20min after injection of study drug or normal saline.

Trial Locations

Locations (1)

The Children's Hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China