Goal-directed Analgesia Using ANI During General Anesthesia in Children With Moyamoya Disease
Effect of Goal-directed Analgesia Using ANI (Analgesia/Nociception Index) During General Anesthesia in Children Undergoing EDAS (Encephaloduroarteriosynangiosis) Surgery for Moyamoya Disease: a Randomized Controlled Trial
1 other identifier
interventional
40
1 country
1
Brief Summary
Analgesia Nociception Index (ANI) has been proposed for the evaluation of the nociception-antinociception balance in the perioperative period. In pediatric patients with Moyamoay disease, where the management of analgesia may be rendered difficult by pharmacological changes, we hypothesised that the monitoring of analgesia with ANI would reduce intraoperative opioid consumption during EDAS surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable pain
Started Jan 2023
Typical duration for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 3, 2023
CompletedStudy Start
First participant enrolled
January 4, 2023
CompletedFirst Posted
Study publicly available on registry
January 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 4, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 4, 2025
CompletedJanuary 9, 2023
January 1, 2023
2 years
January 3, 2023
January 5, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
the mean hourly intraoperative sufentanil requirement
from induction of anesthesia to end of operation, about 5 hours
Secondary Outcomes (2)
the amount of non-opioids analgesic requirements
from induction of anesthesia to end of operation, about 5 hours
the amount of vasoactive agents requirements
from induction of anesthesia to end of operation, about 5 hours
Study Arms (2)
ANI (Analgesia/Nociception Index) monitoring
EXPERIMENTALStandard monitoring
ACTIVE COMPARATORInterventions
Intraoperative analgesia was provided by injection of sufentanil, which was performed according to ANI monitor.
Intraoperative analgesia was provided by injection of sufentanil, which was performed according to the clinician's assessment.
Eligibility Criteria
You may qualify if:
- Pediatric patients receiving EDAS surgery for Moyamoya disease
You may not qualify if:
- ASA (American society of anesthsiologists classification) 4-5
- Emergency surgery
- patients with chronic pain on medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul national university hospital
Seoul, South Korea
Related Publications (1)
Park JB, Kang P, Ji SH, Jang YE, Lee JH, Kim JT, Kim HS, Kim EH. Effects of goal-directed analgesia using the analgesia nociception index in children undergoing surgery for moyamoya disease: A randomised controlled trial. Eur J Anaesthesiol. 2024 Sep 1;41(9):649-656. doi: 10.1097/EJA.0000000000002013. Epub 2024 Jun 3.
PMID: 38832435DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
January 3, 2023
First Posted
January 5, 2023
Study Start
January 4, 2023
Primary Completion
January 4, 2025
Study Completion
January 4, 2025
Last Updated
January 9, 2023
Record last verified: 2023-01