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

Qiu jinpeng

Status: Completed

Conditions: Inguinal Hernia

Treatments: Drug: 0.2mg/kg esketamine; Drug: 0.1ml/kg normal saline; Drug: 0.1mg/kg esketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT06789185

2024-IRB-0377-P-01

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: All

Ages: 24 to 71 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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96 participants in 3 patient groups, including a placebo group

group S1 (0.1mg/kg esketamine)

Experimental group

Treatment:

Drug: 0.1mg/kg esketamine

group S2 (0.2mg/kg esketamine)

Experimental group

Treatment:

Drug: 0.2mg/kg esketamine

group C (0.1ml/kg Normal saline)

Placebo Comparator group

Treatment:

Drug: 0.1ml/kg normal saline