Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06571890
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-04-02
Brief Title:
Emergence Agitation in Paediatric Day Care Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Emergence Agitation in Paediatric Day Care Surgery A Randomised Single-blinded Study Comparing Narcotrend and Heart Rate Variability With Standard Monitoring
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 abdominalinguinal 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 mcgkg 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
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 mcgkg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None