Scalp Nerve Block on Emergence Agitation

January 23, 2017 updated by: Jong Yeop Kim, Ajou University School of Medicine

The Effect of Scalp Nerve Block on the Emergence Agitation in Children Undergoing Nevus Surgery During Sevoflurane Anesthesia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • Korea, Republic of
    • Gyeongki-do
      • Suwon, Gyeongki-do, Korea, Republic of, 443-721
        • Ajou University Hospital

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

1 year to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • developmental disorder
  • neurologic disorder
  • coaguloparthy
  • allergy to local anesthetics

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nerve block
Scalp nerve block was performed with 0.25% ropivacaine.
Drug: Ropivacaine
0.25% ropivacaine 2-3 ml was injected around the scalp nerves that are located on the head.
Drug: Sevoflurane
Anesthesia was titrated with sevoflurane, maintaining mean arterial pressure and heart rate within 20% baseline value.
Active Comparator: Control
Remifentanil was administered intravenously.
Drug: Sevoflurane
Anesthesia was titrated with sevoflurane, maintaining mean arterial pressure and heart rate within 20% baseline value.
Drug: Remifentanil
Remifentanil 1 μg/kg was injected before skin incision.
Other Names:
  • Ultiva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change of Watcha behavior scale for emergence agitation (4 point)
Time Frame: from immediately after PACU arrival to 10 min, 20 min, and 30 min after arrival
from immediately after PACU arrival to 10 min, 20 min, and 30 min after arrival

Collaborators and Investigators

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

Sponsor

Ajou University School of Medicine

Investigators

  • Study Director: Jong Yeop Kim, MD, Ajou University School of Medicine

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

May 1, 2015

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

April 21, 2015

First Submitted That Met QC Criteria

April 23, 2015

First Posted (Estimate)

April 28, 2015

Study Record Updates

Last Update Posted (Estimate)

January 25, 2017

Last Update Submitted That Met QC Criteria

January 23, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AJIRB-MED-CT4-14-422

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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