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Completed

NCT Number: NCT02428283

Scalp Nerve Block on Emergence Agitation

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.

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Key information

Conditions

Agitation Aberrant Motor Behavior in Dementia Behavior Behavioral Symptoms Dyskinesias Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychomotor Agitation Psychomotor Disorders Signs and Symptoms

Age range

1 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ajou University Hospital

Suwon, Gyeongki-do, 443-721, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Ropivacaine

Drug

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

Remifentanil

Drug

Remifentanil 1 μg/kg was injected before skin incision.

Other names: Ultiva

Sevoflurane

Drug

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 28, 2015
Registry last updated
Jan 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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