Emergence Agitation in Pediatric Strabismus Surgery
The Effects of Remifentanil and Fentanyl on Emergence Agitation in Pediatric Strabismus Surgery
1 other identifier
interventional
90
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2017
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 5, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 5, 2018
CompletedFirst Submitted
Initial submission to the registry
January 14, 2019
CompletedFirst Posted
Study publicly available on registry
January 16, 2019
CompletedJanuary 23, 2019
January 1, 2019
1.2 years
January 14, 2019
January 20, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
incidence of postoperative agitation
0=none; 1=occur
5 minutes in the recovery room
incidence of postoperative agitation
0=none; 1=occur
30 minutes in the recovery room
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
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
Study Arms (2)
fentanyl
ACTIVE COMPARATORA bolus dose of fentanyl 2 μg/kg was administered intravenously at anesthetic induction
remifentanil
ACTIVE COMPARATORRemifentanil was continuously infused at a rate of 0.2 μg/kg/min from anesthetic induction to the end of surgery
Interventions
Eligibility Criteria
You may qualify if:
- patients undergoing elective subumbilical surgery,
- physical status was American Society of Anesthesiologists (ASA) class 1 or 2
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Eun kyung Choi
Daegu, Korea (the Republic Of), 41944, South Korea
Yeungnam University Hospital
Daegu, Nam-gu, Daegu, 42415, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 14, 2019
First Posted
January 16, 2019
Study Start
July 7, 2017
Primary Completion
October 5, 2018
Study Completion
October 5, 2018
Last Updated
January 23, 2019
Record last verified: 2019-01