- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03807011
Emergence Agitation in Pediatric Strabismus Surgery
January 20, 2019 updated by: Eun Kyung Choi, Yeungnam University College of Medicine
The Effects of Remifentanil and Fentanyl on Emergence Agitation in Pediatric Strabismus Surgery
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Korea (the Republic Of)
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Daegu, Korea (the Republic Of), Korea, Republic of, 41944
- Eun kyung Choi
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Nam-gu, Daegu
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Daegu, Nam-gu, Daegu, Korea, Republic of, 42415
- Yeungnam University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 8 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: fentanyl
A bolus dose of fentanyl 2 μg/kg was administered intravenously at anesthetic induction
|
fentanyl 2 μg/kg
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ACTIVE_COMPARATOR: remifentanil
Remifentanil was continuously infused at a rate of 0.2 μg/kg/min from anesthetic induction to the end of surgery
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remifentanil 0.2 μg/kg/min
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incidence of postoperative agitation
Time Frame: 5 minutes in the recovery room
|
0=none; 1=occur
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5 minutes in the recovery room
|
incidence of postoperative agitation
Time Frame: 30 minutes in the recovery room
|
0=none; 1=occur
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30 minutes in the recovery room
|
severity of postoperative agitation
Time Frame: 5 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)
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5 minutes in the recovery room
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severity of postoperative agitation
Time Frame: 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)
|
30 minutes in the recovery room
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 7, 2017
Primary Completion (ACTUAL)
October 5, 2018
Study Completion (ACTUAL)
October 5, 2018
Study Registration Dates
First Submitted
January 14, 2019
First Submitted That Met QC Criteria
January 14, 2019
First Posted (ACTUAL)
January 16, 2019
Study Record Updates
Last Update Posted (ACTUAL)
January 23, 2019
Last Update Submitted That Met QC Criteria
January 20, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Eye Diseases
- Postoperative Complications
- Neurologic Manifestations
- Confusion
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Dyskinesias
- Psychomotor Disorders
- Cranial Nerve Diseases
- Ocular Motility Disorders
- Delirium
- Psychomotor Agitation
- Strabismus
- Emergence Delirium
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Remifentanil
- Fentanyl
Other Study ID Numbers
- YUMC 2017-04-071
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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