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Scalp Nerve Block on Emergence Agitation

Sponsor
Ajou University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT02428283
Collaborator
(none)
44
Enrollment
1
Location
2
Arms
18.1
Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
The Effect of Scalp Nerve Block on the Emergence Agitation in Children Undergoing Nevus Surgery During Sevoflurane Anesthesia
Study Start Date :
May 1, 2015
Actual Primary Completion Date :
Nov 1, 2016
Actual Study Completion Date :
Nov 1, 2016

Arms and Interventions

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: Remifentanil
Remifentanil 1 μg/kg was injected before skin incision.
Other Names:
  • Ultiva

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

    Outcome Measures

    Primary Outcome Measures

    1. change of Watcha behavior scale for emergence agitation (4 point) [from immediately after PACU arrival to 10 min, 20 min, and 30 min after arrival]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 7 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • ASA I-II patients undergoing general anesthesia for nevus surgery
    Exclusion Criteria:

    • developmental disorder

    • neurologic disorder

    • coaguloparthy

    • allergy to local anesthetics

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ajou University Hospital Suwon Gyeongki-do Korea, Republic of 443-721

    Sponsors and Collaborators

    • Ajou University School of Medicine

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jong Yeop Kim, Associate professor, Ajou University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT02428283
    Other Study ID Numbers:
    • AJIRB-MED-CT4-14-422
    First Posted:
    Apr 28, 2015
    Last Update Posted:
    Jan 25, 2017
    Last Verified:
    Jan 1, 2017
    Additional relevant MeSH terms:
    Psychomotor Agitation
    Emergence Delirium
    Remifentanil
    Ropivacaine
    Sevoflurane

    Study Results

    No Results Posted as of Jan 25, 2017