The Effect of Remifentanil Infusion During Emergence on the Incidence of Emergence Delirium
1 other identifier
interventional
86
1 country
1
Brief Summary
The aim of the present study is to assess the effect of postoperative remifentanil infusion on the incidence of emergence agitation in preschool-aged children undergoing strabismus surgery with sevoflurane anaesthesia.
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 Apr 2014
Typical duration for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
March 31, 2014
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedFirst Posted
Study publicly available on registry
April 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedJuly 16, 2015
July 1, 2015
2 years
March 31, 2014
July 14, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
the scale of emergence agitation
A blinded observer record emergence agitation at just after laryngeal mask removal, 5 minutes after arrival in postanesthetic care unit, 10 minutes after arrival in postanesthetic care unit, 15 minutes after arrival in postanesthetic care unit, 30 minutes after arrival in postanesthetic care unit, and 30 minutes after discharge from postanesthetic care unit.
up to 30 minutes after arrival in postanesthetic care unit, and 30 minutes after discharge from postanesthetic care unit.
Secondary Outcomes (1)
the effect of remifentanil on the emergence
up to 30 minutes after the discharge form postanesthetic care unit
Study Arms (2)
remifentanil group
EXPERIMENTALRemifentanil 0.05 ug/kg/min is infused to the patients.
control
PLACEBO COMPARATORNormal saline 0.2 ml/kg/hour is infused to the patients
Interventions
Children randomised to remifentanil group receive remifentanil 0.05 ug/kg/min. Children randomised to control group receive normal saline (placebo)
Eligibility Criteria
You may qualify if:
- American Society of Anesthesiologists physical status I and II
- preschool-aged children undergoing strabismus surgery
You may not qualify if:
- psychological disorders
- emotional disorders
- abnormal cognitive development
- developmental delay
- allergy to the drugs in our protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology and Pain Medicine, Yeungnam University hospital
Daegu, 705-035, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sangjin Park, M.D.
Department of Anesthesiology and Pain Medicine, College of medicine, Yeungnam University, Daemyung-Dong, Nam-Gu, Daegu, Republic of Korea
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant professor
Study Record Dates
First Submitted
March 31, 2014
First Posted
April 9, 2014
Study Start
April 1, 2014
Primary Completion
April 1, 2016
Study Completion
May 1, 2016
Last Updated
July 16, 2015
Record last verified: 2015-07