Goal-directed Analgesia Using ANI During General Anesthesia in Children With Moyamoya Disease
Primary Purpose
Pain
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ANI (Analgesia/Nociception Index) monitoring
standard monitoring
Sufentanil
Sponsored by
About this trial
This is an interventional other trial for Pain
Eligibility Criteria
Inclusion Criteria: Pediatric patients receiving EDAS surgery for Moyamoya disease Exclusion Criteria: ASA (American society of anesthsiologists classification) 4-5 Emergency surgery patients with chronic pain on medication
Sites / Locations
- Seoul national university hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ANI (Analgesia/Nociception Index) monitoring
Standard monitoring
Arm Description
Outcomes
Primary Outcome Measures
the mean hourly intraoperative sufentanil requirement
Secondary Outcome Measures
the amount of non-opioids analgesic requirements
the amount of vasoactive agents requirements
Full Information
NCT ID
NCT05672212
First Posted
January 3, 2023
Last Updated
January 5, 2023
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05672212
Brief Title
Goal-directed Analgesia Using ANI During General Anesthesia in Children With Moyamoya Disease
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 4, 2023 (Actual)
Primary Completion Date
January 4, 2025 (Anticipated)
Study Completion Date
January 4, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ANI (Analgesia/Nociception Index) monitoring
Arm Type
Experimental
Arm Title
Standard monitoring
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
ANI (Analgesia/Nociception Index) monitoring
Intervention Description
Intraoperative analgesia was provided by injection of sufentanil, which was performed according to ANI monitor.
Intervention Type
Device
Intervention Name(s)
standard monitoring
Intervention Description
Intraoperative analgesia was provided by injection of sufentanil, which was performed according to the clinician's assessment.
Intervention Type
Drug
Intervention Name(s)
Sufentanil
Intervention Description
Sufentanil
Primary Outcome Measure Information:
Title
the mean hourly intraoperative sufentanil requirement
Time Frame
from induction of anesthesia to end of operation, about 5 hours
Secondary Outcome Measure Information:
Title
the amount of non-opioids analgesic requirements
Time Frame
from induction of anesthesia to end of operation, about 5 hours
Title
the amount of vasoactive agents requirements
Time Frame
from induction of anesthesia to end of operation, about 5 hours
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pediatric patients receiving EDAS surgery for Moyamoya disease
Exclusion Criteria:
ASA (American society of anesthsiologists classification) 4-5
Emergency surgery
patients with chronic pain on medication
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eun-hee Kim
Phone
+82-2-2072-3664
Email
beloveun@snu.ac.kr
Facility Information:
Facility Name
Seoul national university hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eun-hee Kim
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Goal-directed Analgesia Using ANI During General Anesthesia in Children With Moyamoya Disease
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