Scalp Nerve Block on Emergence Agitation

Agitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02428283
• Other study ID #: AJIRB-MED-CT4-14-422
• Status: Completed
• Phase: Phase 4
• First received: April 21, 2015
• Last updated: January 23, 2017
• Start date: May 2015
• Est. completion date: November 2016

Study information

• Verified date: January 2017
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 7 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• developmental disorder

• neurologic disorder

• coaguloparthy

• allergy to local anesthetics

Related Conditions & MeSH terms

• Agitation
• Psychomotor Agitation

Intervention

Drug:
• Ropivacaine
0.25% ropivacaine 2-3 ml was injected around the scalp nerves that are located on the head.
• Remifentanil
Remifentanil 1 µg/kg was injected before skin incision.
• Sevoflurane
Anesthesia was titrated with sevoflurane, maintaining mean arterial pressure and heart rate within 20% baseline value.

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Hospital	Suwon	Gyeongki-do

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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