Emergence Agitation in Pediatric Strabismus Surgery

Not Applicable

Completed

• Conditions: Emergence Agitation
• Interventions: Drug: fentanyl group; Drug: remifentanil group

• Registration Number: NCT03807011
• Lead Sponsor: Yeungnam University College of Medicine

Brief Summary

This study was performed to assess the effects of continuous remifentanil infusion and single bolus administration of fentanyl on the incidence of emergence agitation in pediatrics undergoing strabismus surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-07
• Primary Completion: 2018-10-05
• Study Completion: 2018-10-05
• Status Verified: 2019-01
• Study First Submitted: 2019-01-14
• Study First Submitted QC: 2019-01-14
• Study First Posted: 2019-01-16
• Last Update Submitted: 2019-01-20
• Last Update Posted: 2019-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• patients undergoing elective subumbilical surgery,
• physical status was American Society of Anesthesiologists (ASA) class 1 or 2

Exclusion Criteria

• history of airway problem,
• upper respiratory tract infection within 2 weeks,
• developmental delay,
• neurological or psychological disease,
• history of allergy to the drugs in our protocol were excluded in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fentanyl	fentanyl group	A bolus dose of fentanyl 2 μg/kg was administered intravenously at anesthetic induction
remifentanil	remifentanil group	Remifentanil was continuously infused at a rate of 0.2 μg/kg/min from anesthetic induction to the end of surgery

Primary Outcome Measures

Name	Time	Method
incidence of postoperative agitation	30 minutes in the recovery room	0=none; 1=occur
severity of postoperative agitation	30 minutes in the recovery room	Four-point agitation scale (0=calm; 1=not calm but could easily become calmed; 3=not easily calmed, moderately agitated and restless; 4=combative, excited, or disoriented)

Trial Locations

Locations (2)

Yeungnam University Hospital; 🇰🇷 Daegu, Nam-gu, Daegu, Korea, Republic of

Eun kyung Choi; 🇰🇷 Daegu, Korea (the Republic Of), Korea, Republic of