Scalp Nerve Block on Emergence Agitation

Phase 4

Completed

• Conditions: Agitation
• Interventions: Drug: Ropivacaine; Drug: Remifentanil; Drug: Sevoflurane

• Registration Number: NCT02428283
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2015-04-21
• Study First Submitted QC: 2015-04-23
• Study First Posted: 2015-04-28
• Study Start: 2015-05
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-23
• Last Update Posted: 2017-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nerve block	Ropivacaine	Scalp nerve block was performed with 0.25% ropivacaine.
Nerve block	Sevoflurane	Scalp nerve block was performed with 0.25% ropivacaine.
Control	Remifentanil	Remifentanil was administered intravenously.
Control	Sevoflurane	Remifentanil was administered intravenously.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ajou University Hospital; 🇰🇷 Suwon, Gyeongki-do, Korea, Republic of