Pupillometry-guided Remifentanil Infusion Versus Conventional Administration in Children
NCT ID: NCT03749811
Last Updated: 2019-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2018-12-04
2021-11-18
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
TRIPLE
Investigator and outcomes assessor does not know in which of the groups the patient is allocated, since the group name will be just recorded as "A" or "B" until data analysis of the last participant is done.
Study Groups
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Pupillometry group
A group of participants who receive remifentanil infusion under pupillometry monitoring.
Pupillometry
After induction of anesthesia and determination of the loss of consciousness of the participant, baseline diameter of pupil is measured by electronic pupillometry device. During anesthesia, participant's pupil diameter is repeatedly measured with 5-minute interval. Pupil dilation of 30% or more compared to baseline is indicative of insufficient analgesia.
Conventional group
A group of participants who receive remifentanil infusion without pupillometry monitoring; their analgesic dose is mainly determined via hemodyamic change.
No interventions assigned to this group
Interventions
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Pupillometry
After induction of anesthesia and determination of the loss of consciousness of the participant, baseline diameter of pupil is measured by electronic pupillometry device. During anesthesia, participant's pupil diameter is repeatedly measured with 5-minute interval. Pupil dilation of 30% or more compared to baseline is indicative of insufficient analgesia.
Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiologists physical status classification (ASA class) I - II
* Patient and his/her parents are willing to participate after explanation of the purpose, materials, methods, possible risks and benefits of the research
Exclusion Criteria
* Preoperative use of analgesics, antipsychotics and/or antiepileptics
* Mental retardation
* Medications related to hindrance of autonomic nerve system activity, e. g., beta blockers
* Underlying ophthalmic diseases
3 Years
12 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Hee-Soo Kim
princial investigator
Principal Investigators
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Hee-Soo Kim, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Dept. of Anesthesiology and Pain Medicine, Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Heesoo Kim
Role: primary
References
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Wildemeersch D, Peeters N, Saldien V, Vercauteren M, Hans G. Pain assessment by pupil dilation reflex in response to noxious stimulation in anaesthetized adults. Acta Anaesthesiol Scand. 2018 Sep;62(8):1050-1056. doi: 10.1111/aas.13129. Epub 2018 Apr 19.
Sabourdin N, Barrois J, Louvet N, Rigouzzo A, Guye ML, Dadure C, Constant I. Pupillometry-guided Intraoperative Remifentanil Administration versus Standard Practice Influences Opioid Use: A Randomized Study. Anesthesiology. 2017 Aug;127(2):284-292. doi: 10.1097/ALN.0000000000001705.
Other Identifiers
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1811-036-984
Identifier Type: -
Identifier Source: org_study_id