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Completed

NCT Number: NCT06571890

Emergence Agitation in Paediatric Day Care Surgery

Emergence agitation is a significant and persistent challenge in paediatric anaesthesia, especially in children of preschool age.

In this study, the investigators examined whether anaesthesia titration with either a sleep depth monitor or a pain monitor would result in changed postoperative agitation rates, measured via the Richmond Agitation and Sedation Score (RASS).

93 children participated. The participants were divided into three groups: A conventional anaesthesia group, an EEG (Electroencephalography)- monitored and a pain-monitored group. The pain-monitored children received the most pain medication but were discharged at the same rate as the other children with unchanged rates of nausea and vomiting and less agitation than the sleep-monitored children.

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Key information

Conditions

Postoperative Delirium Anesthesia Anesthesia Nociception Index Confusion Delirium Emergence Delirium Heart Rate Variability Mdoloris Mental Disorders Narcotrend Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pain Monitoring Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Agitation Postoperative Complications Signs and Symptoms

Age range

1 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Odense University Hospital

Odense, 5000, Denmark

About this study

Healthy preschool outpatients assigned for abdominal/inguinal hernia and cryptorchidism repairs participated after parental consent.

One group received standard anaesthesia induction and maintenance, according to the usual ward regimen. This was done with sevoflurane inhalation, fentanyl bolus and a laryngeal mask airway (Standard group, STD group)

The second group received standard anaesthesia as well only this time the sevoflurane titration was guided via the Nacotrend bispectral index monitor, towards a narcotrend index of 2-4. (Narcotrend group, NCT group)

The third group also received standard anaesthesia and was additionally monitored with a Mdoloris Anaesthesia Nociception Index (ANI) monitor for perioperative nociception. When a nociceptive threshold was exceeded, an extra bolus of fentanyl of 1 mcg/kg was given (ANI group)

All children were then escorted to the postoperative care unit for wakeup. A Richmond Agitation Sedation Scale score (RASS-score) was made every 15 minutes until discharge. This was analysed with Kaplan-Meyer mortality graph, along with usual statistics of secondary outcomes.

The children in the ANI group received the least fentanyl and were discharged no later than all the other children.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Day surgery for abdominal and urological procedures
  • Children 1-6 years
  • American Society of Anesthesiologist (ASA) scale 1- 2
  • Airway management with laryngeal masks or facemasks
  • Consent from both parents/legal representatives
  • Rescue propofol is allowed

Exclusion criteria

  • Age less than 1 or older than 6 years
  • ASA > 2
  • Endotracheal intubation;
  • Lack of consent from both parents/legal representatives
  • Daily intake of medications that interfered with the autonomic nervous system reactivity, for example, inhaled beta-agonists for bronchial asthma and total intravenous anaesthesia (TIVA).

Treatment and study plan

Narcotrend bispectral index anaesthesia monitor

Device

A bispectral index anaesthesia monitor collects simplified EEG via forehead electrodes and displays an index of 0-100, where an index of 40-60 is considered optimal

Mdoloris Anaesthesia Nociception Monitor

Device

A heart rate variability-based nociception monitor collects ECG-signal from electrodes on the patient's chest and displays an index of 0-100 where an index below 50 is considered nociceptive.

Primary outcomes

  1. Richmond Agitation Sedation Scale Score

    Time frame: During postoperative care unit (PACU) stay within 0-8 hours

    Scoring system for sedation and agitation from -5 til +4.

Secondary outcomes

  1. Time consumption

    Time frame: Within 48 hours of hospital admission

    Time spent with anesthesia, PACU stay and total time.

  2. Fentanyl consumption

    Time frame: Within 48 hours of hospital admission

    Given during the anesthesia against postoperative pain

  3. Nurse-VAS

    Time frame: Within the duration of PACU stay of 0-8 hours

    A Visual-Analogue-Scale score (VAS score) assessed by PACU nurses. A score from 0-10 where 10 represents worst pain.

  4. PONV

    Time frame: Within the duration of PACU stay of 0-8 hours

    Postoperative nausea and vomiting (PONV). A score from 0-2 where 2 represents worst nausea and vomiting.

  5. Other medications

    Time frame: During the first 24 postoperative hours

    Other drugs, such as NSAIDs, given

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Odense Patient Data Explorative Network

Registry information

Official study title

Emergence Agitation in Paediatric Day Care Surgery: A Randomised, Single-blinded Study Comparing Narcotrend and Heart Rate Variability With Standard Monitoring

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 26, 2024
Registry last updated
Aug 26, 2024

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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