Anesthesia, Anesthesia Nociception Index, Heart Rate Variability, Mdoloris, Narcotrend, Pain Monitoring, Postoperative Agitation, Postoperative Delirium
Conditions
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.
Interventions
DEVICENarcotrend 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
DEVICEMdoloris 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.
Sponsors
Odense Patient Data Explorative Network
University of Southern Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 6 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Time consumption | Within 48 hours of hospital admission | Time spent with anesthesia, PACU stay and total time. |
| 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. |
| 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. |
| Other medications | During the first 24 postoperative hours | Other drugs, such as NSAIDs, given |
Countries
Denmark
Outcome results
None listed