Emergence Agitation in Paediatric Day Care Surgery

Not Applicable

Completed

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

• Registration Number: NCT06571890
• Lead Sponsor: University of Southern Denmark

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.

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 Timeline

• Study Start: 2019-03-29
• Primary Completion: 2020-06-12
• Study Completion: 2020-09-30
• Study First Submitted: 2024-04-02
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-25
• Last Update Submitted: 2024-08-25
• Study First Posted: 2024-08-26
• Last Update Posted: 2024-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anaesthesia Nociception Index Monitor (ANI)	Mdoloris Anaesthesia Nociception Monitor	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
Narcotrend (NCT)	Narcotrend bispectral index anaesthesia monitor	Standard anaesthesia with Sevoflurane inhalation anaesthesia, fentanyl and a laryngeal mask. Sevoflurane concentration was titrated via a Narcotrend bispectral anaesthesia monitor.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Fentanyl consumption	Within 48 hours of hospital admission	Given during the anesthesia against postoperative pain
Nurse-VAS	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.
Other medications	During the first 24 postoperative hours	Other drugs, such as NSAIDs, given
PONV	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.
Time consumption	Within 48 hours of hospital admission	Time spent with anesthesia, PACU stay and total time.

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Denmark