Scalp Nerve Block on Emergence Agitation

NCT ID: NCT02428283

Last Updated: 2017-01-25

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-11-30

Brief Summary

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Emergence agitation is a common problem in children during recovery from sevoflurane anesthesia. Pain is considered as a cause of postoperative emergence agitation and compounding factor of agitation assessment in children. The purpose of this study was to investigate the effect of scalp nerve block on the emergence agitation in children undergoing nevus surgery during sevoflurane anesthesia.

Detailed Description

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Forty-four children, 1-7 years old, undergoing nevus surgery on head were enrolled. Anesthesia was induced with thiopental sodium and rocuronium, and maintained with sevoflurane. Patients were randomly assigned two groups: the control group received IV remifentanil 1 μg/kg, and the block group received scalp nerve block with 0.25% ropivacaine 2-3 ml. Time to tracheal extubation, recovery time, hemodynamic change, FLACC score, and Watcha behavior scale for emergence agitation were assessed.

Conditions

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Agitation

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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Nerve block

Scalp nerve block was performed with 0.25% ropivacaine.

Group Type EXPERIMENTAL

Ropivacaine

Intervention Type DRUG

0.25% ropivacaine 2-3 ml was injected around the scalp nerves that are located on the head.

Sevoflurane

Intervention Type DRUG

Anesthesia was titrated with sevoflurane, maintaining mean arterial pressure and heart rate within 20% baseline value.

Control

Remifentanil was administered intravenously.

Group Type ACTIVE_COMPARATOR

Remifentanil

Intervention Type DRUG

Remifentanil 1 μg/kg was injected before skin incision.

Sevoflurane

Intervention Type DRUG

Anesthesia was titrated with sevoflurane, maintaining mean arterial pressure and heart rate within 20% baseline value.

Interventions

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Ropivacaine

0.25% ropivacaine 2-3 ml was injected around the scalp nerves that are located on the head.

Intervention Type DRUG

Remifentanil

Remifentanil 1 μg/kg was injected before skin incision.

Intervention Type DRUG

Sevoflurane

Anesthesia was titrated with sevoflurane, maintaining mean arterial pressure and heart rate within 20% baseline value.

Intervention Type DRUG

Other Intervention Names

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Ultiva

Eligibility Criteria

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Inclusion Criteria

* ASA I-II patients undergoing general anesthesia for nevus surgery

Exclusion Criteria

* developmental disorder
* neurologic disorder
* coaguloparthy
* allergy to local anesthetics
Minimum Eligible Age

1 Year

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ajou University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Jong Yeop Kim

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jong Yeop Kim, MD

Role: STUDY_DIRECTOR

Ajou University School of Medicine

Locations

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Ajou University Hospital

Suwon, Gyeongki-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AJIRB-MED-CT4-14-422

Identifier Type: -

Identifier Source: org_study_id

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