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Scalp Nerve Block on Emergence Agitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02428283
Recruitment Status : Completed
First Posted : April 28, 2015
Last Update Posted : January 25, 2017
Sponsor:
Information provided by (Responsible Party):
Jong Yeop Kim, Ajou University School of Medicine

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
Agitation Drug: Ropivacaine Drug: Remifentanil Drug: Sevoflurane 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.

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Study Type : Interventional  (Clinical Trial)
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 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birthmarks Moles

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 Name: Ultiva

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




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   1 Year to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02428283


Locations
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Korea, Republic of
Ajou University Hospital
Suwon, Gyeongki-do, Korea, Republic of, 443-721
Sponsors and Collaborators
Ajou University School of Medicine
Investigators
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Study Director: Jong Yeop Kim, MD Ajou University School of Medicine
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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: April 28, 2015    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Psychomotor Agitation
Emergence Delirium
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Delirium
Confusion
Postoperative Complications
Pathologic Processes
Neurocognitive Disorders
Mental Disorders
Remifentanil
Ropivacaine
Sevoflurane
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General