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NCT05672212 Clinical Trial

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

Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05672212
Other study ID # 2211-149-1381
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 4, 2023
Est. completion date January 4, 2025

Study information
Verified date January 2023
Source Seoul National University Hospital
Contact Eun-hee Kim
Phone +82-2-2072-3664
Email beloveun@snu.ac.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date January 4, 2025
Est. primary completion date January 4, 2025
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• ANI (Analgesia/Nociception Index) monitoring
Intraoperative analgesia was provided by injection of sufentanil, which was performed according to ANI monitor.
• standard monitoring
Intraoperative analgesia was provided by injection of sufentanil, which was performed according to the clinician's assessment.
Drug:
• Sufentanil
Sufentanil

Locations
Country Name City State
Korea, Republic of Seoul national university hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary the mean hourly intraoperative sufentanil requirement from induction of anesthesia to end of operation, about 5 hours
Secondary the amount of non-opioids analgesic requirements from induction of anesthesia to end of operation, about 5 hours
Secondary the amount of vasoactive agents requirements from induction of anesthesia to end of operation, about 5 hours
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