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Completed

NCT Number: NCT06789185

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.

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Key information

Conditions

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

Age range

24 month–71 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310052, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

0.1mg/kg esketamine

Drug

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

0.2mg/kg esketamine

Drug

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

0.1ml/kg normal saline

Drug

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

Primary outcomes

  1. The incidence of emergence delirium

    Time frame: 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 outcomes

  1. Tracheal catheter extubation time

    Time frame: Within up to 30 minutes after operation

    The time from the cessation of sevoflurane to the point when the tracheal catheter would be remove.

  2. emergence from anesthesia time

    Time frame: 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.

  3. The incidence of postoperative pain

    Time frame: 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.

  4. Recovery time

    Time frame: 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.

  5. The incidence of adverse effects

    Time frame: 24 hours after surgery.

    Postoperative nausea, vomiting, salivation, bradycardia, hypotension, and respiratory depression within 24 hours after surgery.

  6. Blood pressure

    Time frame: 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.

  7. heart rate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Qiu jinpeng

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 23, 2025
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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