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

January 5, 2023 updated by: Eun-hee Kim, Seoul National University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Eun-hee Kim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the mean hourly intraoperative sufentanil requirement
Time Frame: from induction of anesthesia to end of operation, about 5 hours
from induction of anesthesia to end of operation, about 5 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
the amount of non-opioids analgesic requirements
Time Frame: from induction of anesthesia to end of operation, about 5 hours
from induction of anesthesia to end of operation, about 5 hours
the amount of vasoactive agents requirements
Time Frame: from induction of anesthesia to end of operation, about 5 hours
from induction of anesthesia to end of operation, about 5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2023

Primary Completion (Anticipated)

January 4, 2025

Study Completion (Anticipated)

January 4, 2025

Study Registration Dates

First Submitted

January 3, 2023

First Submitted That Met QC Criteria

January 4, 2023

First Posted (Actual)

January 5, 2023

Study Record Updates

Last Update Posted (Estimate)

January 9, 2023

Last Update Submitted That Met QC Criteria

January 5, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2211-149-1381

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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