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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.
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.
Age
1 - 6 years
Sex
ALL
Healthy Volunteers
No
Odense University Hospital
Odense, Denmark
Start Date
March 29, 2019
Primary Completion Date
June 12, 2020
Completion Date
September 30, 2020
Last Updated
August 26, 2024
93
ACTUAL participants
Narcotrend bispectral index anaesthesia monitor
DEVICE
Mdoloris Anaesthesia Nociception Monitor
DEVICE
Lead Sponsor
University of Southern Denmark
Collaborators
NCT06346132
NCT06430957
Data Source & Attribution
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