Emergence Agitation in Paediatric Day Care Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Delirium; Anesthesia; Heart Rate Variability; Narcotrend; Pain Monitoring; Postoperative Agitation; Mdoloris; Anesthesia Nociception Index
• Intervention / Treatment: Device: Narcotrend bispectral index anaesthesia monitor; Device: Mdoloris Anaesthesia Nociception Monitor

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard (STD); Standard anaesthesia with Sevoflurane Inhalation anaesthesia, fentanyl and a laryngeal mask
Experimental: Narcotrend (NCT); Standard anaesthesia with Sevoflurane inhalation anaesthesia, fentanyl and a laryngeal mask. Sevoflurane concentration was titrated via a Narcotrend bispectral anaesthesia monitor.	Device: Narcotrend bispectral index anaesthesia monitor; 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
Experimental: Anaesthesia Nociception Index Monitor (ANI); Standard anaesthesia with Sevoflurane inhalation anaesthesia, fentanyl and a laryngeal mask. Fentanyl dosage titrated with guidance from Mdoloris ANI monitor, a heart rate variability-based nociception monitor. When a threshold value is exceeded, additional fentanyl 1 mcg/kg is given	Device: Mdoloris Anaesthesia Nociception Monitor; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Richmond Agitation Sedation Scale Score	Scoring system for sedation and agitation from -5 til +4.	During postoperative care unit (PACU) stay within 0-8 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time consumption	Time spent with anesthesia, PACU stay and total time.	Within 48 hours of hospital admission
Fentanyl consumption	Given during the anesthesia against postoperative pain	Within 48 hours of hospital admission
Nurse-VAS	A Visual-Analogue-Scale score (VAS score) assessed by PACU nurses. A score from 0-10 where 10 represents worst pain.	Within the duration of PACU stay of 0-8 hours
PONV	Postoperative nausea and vomiting (PONV). A score from 0-2 where 2 represents worst nausea and vomiting.	Within the duration of PACU stay of 0-8 hours
Other medications	Other drugs, such as NSAIDs, given	During the first 24 postoperative hours

Collaborators and Investigators

• Sponsor: University of Southern Denmark
• Collaborators: Odense Patient Data Explorative Network
• Investigators: Principal Investigator: Line Gry Larsen, Anaeshtesiologic Intensive Ward V, Odense University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2019
• Primary Completion (Actual): June 12, 2020
• Study Completion (Actual): September 30, 2020

Study Registration Dates

• First Submitted: April 2, 2024
• First Submitted That Met QC Criteria: August 25, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): August 26, 2024
• Last Update Submitted That Met QC Criteria: August 25, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Dyskinesias; Psychomotor Disorders; Delirium; Aberrant Motor Behavior in Dementia; Psychomotor Agitation; Emergence Delirium; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 280482

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No