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Scalp Nerve Block on Emergence Agitation

Primary Purpose

Agitation

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ropivacaine
Remifentanil
Sevoflurane
Sponsored by
Ajou University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Agitation

Eligibility Criteria

1 Year - 7 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Ajou University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nerve block

Control

Arm Description

Scalp nerve block was performed with 0.25% ropivacaine.

Remifentanil was administered intravenously.

Outcomes

Primary Outcome Measures

change of Watcha behavior scale for emergence agitation (4 point)

Secondary Outcome Measures

Full Information

First Posted
April 21, 2015
Last Updated
January 23, 2017
Sponsor
Ajou University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02428283
Brief Title
Scalp Nerve Block on Emergence Agitation
Official Title
The Effect of Scalp Nerve Block on the Emergence Agitation in Children Undergoing Nevus Surgery During Sevoflurane Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agitation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nerve block
Arm Type
Experimental
Arm Description
Scalp nerve block was performed with 0.25% ropivacaine.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Remifentanil was administered intravenously.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
0.25% ropivacaine 2-3 ml was injected around the scalp nerves that are located on the head.
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Other Intervention Name(s)
Ultiva
Intervention Description
Remifentanil 1 μg/kg was injected before skin incision.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
Anesthesia was titrated with sevoflurane, maintaining mean arterial pressure and heart rate within 20% baseline value.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA I-II patients undergoing general anesthesia for nevus surgery Exclusion Criteria: developmental disorder neurologic disorder coaguloparthy allergy to local anesthetics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong Yeop Kim, MD
Organizational Affiliation
Ajou University School of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Ajou University Hospital
City
Suwon
State/Province
Gyeongki-do
ZIP/Postal Code
443-721
Country
Korea, Republic of

12. IPD Sharing Statement

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Scalp Nerve Block on Emergence Agitation

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