Clinical trial NCT06571890: Emergence Agitation in Paediatric Day Care Surgery
Official title: Emergence Agitation in Paediatric Day Care Surgery: A Randomised, Single-blinded Study Comparing Narcotrend and Heart Rate Variability With Standard Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Delirium
Postoperative Agitation
Anesthesia
Pain Monitoring
Heart Rate Variability
Narcotrend
Mdoloris
Anesthesia Nociception Index
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Odense Patient Data Explorative Network
First posted: 2024-08-26
Enrollment: 93
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Richmond Agitation Sedation Scale Score
timeFrame: During postoperative care unit (PACU) stay within 0-8 hours
Secondary outcomes:
measure: Time consumption
timeFrame: Within 48 hours of hospital admission
measure: Fentanyl consumption
timeFrame: Within 48 hours of hospital admission
measure: Nurse-VAS
timeFrame: Within the duration of PACU stay of 0-8 hours
measure: PONV
timeFrame: Within the duration of PACU stay of 0-8 hours
measure: Other medications
timeFrame: During the first 24 postoperative hours
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Anaeshtesiologic Intensive Ward V, Odense University Hospital
name: Line Gry Larsen
role: PRINCIPAL_INVESTIGATOR
References: