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

NCT ID: NCT05672212

Last Updated: 2023-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-04

Study Completion Date

2025-01-04

Brief Summary

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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.

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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ANI (Analgesia/Nociception Index) monitoring

Group Type EXPERIMENTAL

ANI (Analgesia/Nociception Index) monitoring

Intervention Type DEVICE

Intraoperative analgesia was provided by injection of sufentanil, which was performed according to ANI monitor.

Sufentanil

Intervention Type DRUG

Sufentanil

Standard monitoring

Group Type ACTIVE_COMPARATOR

standard monitoring

Intervention Type DEVICE

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

Sufentanil

Intervention Type DRUG

Sufentanil

Interventions

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ANI (Analgesia/Nociception Index) monitoring

Intraoperative analgesia was provided by injection of sufentanil, which was performed according to ANI monitor.

Intervention Type DEVICE

standard monitoring

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

Intervention Type DEVICE

Sufentanil

Sufentanil

Intervention Type DRUG

Eligibility Criteria

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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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Eun-hee Kim

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul national university hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Eun-hee Kim

Role: CONTACT

+82-2-2072-3664

Facility Contacts

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Eun-hee Kim

Role: primary

References

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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.

Reference Type DERIVED
PMID: 38832435 (View on PubMed)

Other Identifiers

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2211-149-1381

Identifier Type: -

Identifier Source: org_study_id

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