Analgesia Nociception Index in Orthognathic Surgery

NCT ID: NCT06205355

Last Updated: 2024-01-16

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

RECRUITING

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-25

Study Completion Date

2026-12-30

Brief Summary

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This study aims to determine whether goal-directed analgesia using ANI(Analgesia/Nociception Index) can improve the quality of postoperative recovery in patients undergoing maxillofacial surgery.

Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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goal-directed analgesia using ANI monitoring

Group Type EXPERIMENTAL

Analgesia/Nociception Index (ANI) monitoring

Intervention Type DEVICE

intraoperative analgesia was provided by infusion of remifentanil via target controlled infusion mode, which was controlled according to ANI monitor.

Standard monitoring

Group Type ACTIVE_COMPARATOR

Standard monitoring

Intervention Type DEVICE

intraoperative analgesia was provided by infusion of remifentanil via target controlled infusion mode, which was controlled according to the clinician's decision

Interventions

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Analgesia/Nociception Index (ANI) monitoring

intraoperative analgesia was provided by infusion of remifentanil via target controlled infusion mode, which was controlled according to ANI monitor.

Intervention Type DEVICE

Standard monitoring

intraoperative analgesia was provided by infusion of remifentanil via target controlled infusion mode, which was controlled according to the clinician's decision

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adult patients 18 or older undergoing maxillary, mandibular, or bimaxillary surgery under general anesthesia.
* adult patients who can provide written informed consent to participate in the study, understand the procedures of this study, and be able to complete patient-reported questionnaires adequately.
* adult patients who Have made an informed decision to participate in this study and have given written consent.

Exclusion Criteria

* Patients with ASA physical status 4-5
* Emergency surgery
* Patients with chronic pain and related pain medications
* Patients with hypersensitivity to general anesthesia drugs and pain medications
* Patients with arrhythmia
* Pregnant women
* Others deemed unsuitable by the investigator
Minimum 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 Children's Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Eun-Hee Kim, M.D., Ph.D.

Role: primary

+82-2-2072-3664

Other Identifiers

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H-2310-152-1481

Identifier Type: -

Identifier Source: org_study_id

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