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

NCT06789185 | Completed DMC

• 1 other identifier: 2024-IRB-0377-P-01
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Tracheal catheter extubation time

  Within up to 30 minutes after operation

• emergence from anesthesia time

  Within up to 30 minutes after operation

• The incidence of postoperative pain

  Within up to 30 minutes after operation

• Recovery time

  Within up to 50 minutes after operation

• The incidence of adverse effects

  24 hours after surgery.

Study Arms (3)

group S1 (0.1mg/kg esketamine)

EXPERIMENTAL

Drug: 0.1mg/kg esketamine

group S2 (0.2mg/kg esketamine)

EXPERIMENTAL

Drug: 0.2mg/kg esketamine

group C (0.1ml/kg Normal saline)

PLACEBO COMPARATOR

Drug: 0.1ml/kg normal saline

Interventions

0.1mg/kg esketamine DRUG

Intravenous injection 0.1mg/kg esketamine about 5min before the end of the surgery

group S1 (0.1mg/kg esketamine)

0.2mg/kg esketamine DRUG

Intravenous injection 0.2mg/kg esketamine about 5min before the end of the surgery

group S2 (0.2mg/kg esketamine)

0.1ml/kg normal saline DRUG

Intravenous injection 0.1ml/kg normal saline about 5min before the end of the surgery

group C (0.1ml/kg Normal saline)

Eligibility Criteria

• Age: 24 Months - 71 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• allergy to esketamine
• abnormal liver or kidney function
• glaucoma or neurological disorders
• cardiovascular or endocrine dysfunction
• asthma or respiratory infection in the last 2 weeks
• developmental delay

Sponsors & Collaborators

• Qiu jinpeng: lead

Study Sites (1)

The Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310052, China

Location

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Esketamine; Saline Solution

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: attending anesthesiologist

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 23, 2025
• Study Start: February 7, 2025
• Primary Completion: May 16, 2025
• Study Completion: May 16, 2025
• Last Updated: May 22, 2025

Record last verified: 2025-05

Locations

CN (1)