Scalp Nerve Block on Emergence Agitation

NCT02428283 | Completed Phase 4 DMC

• 1 other identifier: AJIRB-MED-CT4-14-422
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Agitation

Outcome Measures

Primary Outcomes (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

Study Arms (2)

Nerve block

EXPERIMENTAL

Scalp nerve block was performed with 0.25% ropivacaine.

Drug: Ropivacaine; Drug: Sevoflurane

Control

ACTIVE COMPARATOR

Remifentanil was administered intravenously.

Drug: Remifentanil; Drug: Sevoflurane

Interventions

Ropivacaine DRUG

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

Nerve block

Remifentanil DRUG

Remifentanil 1 μg/kg was injected before skin incision.

Also known as: Ultiva

Control

Sevoflurane DRUG

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

Control; Nerve block

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ajou University School of Medicine: lead

Study Sites (1)

Ajou University Hospital

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

Location

MeSH Terms

Conditions

Psychomotor Agitation

Interventions

Ropivacaine; Remifentanil; Sevoflurane

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Jong Yeop Kim, MD

  Ajou University School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 21, 2015
• First Posted: April 28, 2015
• Study Start: May 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: January 25, 2017

Record last verified: 2017-01

Locations

KR (1)