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Goal-directed Analgesia Using ANI During General Anesthesia in Children With Moyamoya Disease

Sponsor
Seoul National University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05672212
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
24
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: ANI (Analgesia/Nociception Index) monitoring
  • Device: standard monitoring
  • Drug: Sufentanil
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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
Actual Study Start Date :
Jan 4, 2023
Anticipated Primary Completion Date :
Jan 4, 2025
Anticipated Study Completion Date :
Jan 4, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: ANI (Analgesia/Nociception Index) monitoring

Device: ANI (Analgesia/Nociception Index) monitoring
Intraoperative analgesia was provided by injection of sufentanil, which was performed according to ANI monitor.

Drug: Sufentanil
Sufentanil
Active Comparator: Standard monitoring

Device: standard monitoring
Intraoperative analgesia was provided by injection of sufentanil, which was performed according to the clinician's assessment.

Drug: Sufentanil
Sufentanil

Outcome Measures

Primary Outcome Measures

  1. the mean hourly intraoperative sufentanil requirement [from induction of anesthesia to end of operation, about 5 hours]

Secondary Outcome Measures

  1. the amount of non-opioids analgesic requirements [from induction of anesthesia to end of operation, about 5 hours]

  2. the amount of vasoactive agents requirements [from induction of anesthesia to end of operation, about 5 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul national university hospital Seoul Korea, Republic of

Sponsors and Collaborators

  • Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eun-hee Kim, professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT05672212
Other Study ID Numbers:
  • 2211-149-1381
First Posted:
Jan 5, 2023
Last Update Posted:
Jan 9, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Moyamoya Disease
Sufentanil

Study Results

No Results Posted as of Jan 9, 2023