Emergence Agitation in Paediatric Day Care Surgery

NCT06571890 | Completed

• 1 other identifier: 280482
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Delirium; Postoperative Agitation; Anesthesia; Pain Monitoring; Heart Rate Variability; Narcotrend; Mdoloris; Anesthesia Nociception Index

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Time consumption

  Within 48 hours of hospital admission

• Fentanyl consumption

  Within 48 hours of hospital admission

• Nurse-VAS

  Within the duration of PACU stay of 0-8 hours

• PONV

  Within the duration of PACU stay of 0-8 hours

• Other medications

  During the first 24 postoperative hours

Study Arms (3)

Standard (STD)

NO INTERVENTION

Standard anaesthesia with Sevoflurane Inhalation anaesthesia, fentanyl and a laryngeal mask

Narcotrend (NCT)

EXPERIMENTAL

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

Anaesthesia Nociception Index Monitor (ANI)

EXPERIMENTAL

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

Interventions

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

Narcotrend (NCT)

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.

Anaesthesia Nociception Index Monitor (ANI)

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Southern Denmark: lead
• Odense Patient Data Explorative Network: collaborator

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Line Gry Larsen

  Anaeshtesiologic Intensive Ward V, Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: August 26, 2024
• Study Start: March 29, 2019
• Primary Completion: June 12, 2020
• Study Completion: September 30, 2020
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)