Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
93 participants
INTERVENTIONAL
2019-03-29
2020-09-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard (STD)
Standard anaesthesia with Sevoflurane Inhalation anaesthesia, fentanyl and a laryngeal mask
No interventions assigned to this group
Narcotrend (NCT)
Standard anaesthesia with Sevoflurane inhalation anaesthesia, fentanyl and a laryngeal mask. Sevoflurane concentration was titrated via a Narcotrend bispectral anaesthesia monitor.
Narcotrend bispectral index anaesthesia monitor
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
Anaesthesia Nociception Index Monitor (ANI)
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
Mdoloris Anaesthesia Nociception Monitor
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.
Interventions
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Narcotrend bispectral index anaesthesia monitor
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
Mdoloris Anaesthesia Nociception Monitor
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
1 Year
6 Years
ALL
No
Sponsors
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Odense Patient Data Explorative Network
OTHER
University of Southern Denmark
OTHER
Responsible Party
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Principal Investigators
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Line Gry Larsen
Role: PRINCIPAL_INVESTIGATOR
Anaeshtesiologic Intensive Ward V, Odense University Hospital
Locations
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Odense University Hospital
Odense, , Denmark
Countries
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Other Identifiers
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280482
Identifier Type: -
Identifier Source: org_study_id
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