Emergence Agitation in Pediatric Strabismus Surgery

Emergence Agitation Clinical Trial

Official title:

The Effects of Remifentanil and Fentanyl on Emergence Agitation in Pediatric Strabismus Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03807011
• Other study ID #: YUMC 2017-04-071
• Status: Completed
• Phase: N/A
• Start date: July 7, 2017
• Est. completion date: October 5, 2018

Study information

• Verified date: January 2019
• Source: Yeungnam University College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 5, 2018
• Est. primary completion date: October 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Emergence Agitation
• Emergence Delirium
• Psychomotor Agitation
• Strabismus

Intervention

Drug:
• fentanyl group
fentanyl 2 µg/kg
• remifentanil group
remifentanil 0.2 µg/kg/min

Locations

Country	Name	City	State
Korea, Republic of	Eun kyung Choi	Daegu	Korea (the Republic Of)
Korea, Republic of	Yeungnam University Hospital	Daegu	Nam-gu, Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Yeungnam University College of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of postoperative agitation	0=none; 1=occur	5 minutes in the recovery room
Primary	incidence of postoperative agitation	0=none; 1=occur	30 minutes in the recovery room
Primary	severity of postoperative agitation	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)	5 minutes in the recovery room
Primary	severity of postoperative agitation	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)	30 minutes in the recovery room