OPEN Research Support

Line Gry Larsen
Anaesthesia and Intensive, Hospital of Southern Jutland

Projekt styring
Projekt status    Sampling ongoing
Data indsamlingsdatoer
Start 01.11.2018  
Slut 31.12.2020  

Postoperative agitation in paediatric outpatiens - a randomized clinical trial with heart frequence variability and EEG monitoring

Short summary

Postoperative agitation is a significant challenge in paediatric anaesthesia.  In this clinical trial we will investigate if postoperative agitation can be reduced with Narcotrend EEG (electroencefalography) monitor or mdoloris ANI (Anaeshtesia Nocioception Index) monitor. 90 healthy children will be included and randomized into three groups:  Conventional,  HRV-guided or EEG-guided anesthesia.


Postoperative agitation is a significant challenge in paediatric anesthesia. In some studies an incidence up to 80% is reported.   It can be difficult to determine if the agitation is caused by pain, delirium or both. Younger children lacks cognitive and vocabulary abilities to explain what is wrong if they are uncomfortable after awakening from anesthesia. Even the incidence of awareness is higher in children.  All this might be reduced with these newer noninvasive monitors.

Simplified EEG monitoring is a well known measure for anaesthetic depth, but it does not detect nociception and is correlated with some uncertainties.

Heart rate variability is a measure for the sympathetic/parasympathetic balance, and derived from this, a nociception index (ANI) can be calculated. This is not, however, a measure for anesthetic depth.  

All patients  in this study will receive anaesthesia with sevoflurane and fentanyl. In the two intervention groups the anaesthesia is adjusted according to the monitors.  

Comparing standard treatment with anaesthesia guided by Narcotrend or ANI might reveal some causality for postoperative agitation.  Our primary outcome measure is the Ramsey Agitation and Sedation Scale (RASS) score . Secondary outcomes are: Time to discharge, pain on 1. postoperative day, use of analgesic drugs and postoperative nausea and vomiting.

To our knowledge, no preexisting studies exists comparing perianaesthetic EEG and ANI monitoring in children. 

Description of the cohort

90 children aged 1-6 years (10-25 kg)

ASA 1-2

No daily medicine (e.g. for asthmatics)

Data and biological material

Data from patient monitors. Patient basic characteristics. RASS-score, pain, admission time, postoperative nausea and vomiting, usage of analgesic medicine including first postoperative day.  No biological material is collected.

Collaborating researchers and departments

Department of Anaesthesiology, Odense University Hospital

  • MD, PhD, Pediatric Anaesthesiologist Tom G. Hansen
  • Doctor in specialist training, Sebastian Lé Greves
  • Doctor in specialist training, Marie Vegger
  • Med. Student Liv Erngaard

Department of Surgery and Intensive Care, Aabenraa Hospital

  • Anaesthesiologist Carsten Thee