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

Seoul National University Hospital1 site in 1 country40 target enrollmentJanuary 4, 2023

ConditionsPain

InterventionsANI (Analgesia/Nociception Index) monitoring Sufentanil standard monitoring

DrugsSufentanil

Overview

Phase: Not Applicable
Intervention: ANI (Analgesia/Nociception Index) monitoring
Conditions: Pain
Sponsor: Seoul National University Hospital
Enrollment: 40
Locations: 1
Primary Endpoint: the mean hourly intraoperative sufentanil requirement
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 4, 2023

End Date

January 4, 2025

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Seoul National University Hospital

Responsible Party

Principal Investigator

Eun-hee Kim

professor

Seoul National University Hospital

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

Arms & Interventions

ANI (Analgesia/Nociception Index) monitoring

Intervention: ANI (Analgesia/Nociception Index) monitoring

ANI (Analgesia/Nociception Index) monitoring

Intervention: Sufentanil

Standard monitoring

Intervention: standard monitoring

Standard monitoring

Intervention: Sufentanil

Outcomes

Primary Outcomes

the mean hourly intraoperative sufentanil requirement

Time Frame: from induction of anesthesia to end of operation, about 5 hours

Secondary Outcomes

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)