An interventional study of Pupillometry in Opioid Use, sponsored by Seoul National University Hospital. Status unknown at 1 site in South Korea. Open to participants aged 3 Years to 12 Years. Per ClinicalTrials.gov, last updated 2019-03-29.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment
Our study aims to compare the total intravenous dose of remifentanil per anesthesia hour and body weight in two groups of pediatric surgical patients - an interventional group with remifentanil infusion under pupillometry monitoring, and control group without pupillometry - to figure out whether pupillometry monitoring may reduce remifentanil consumption during anesthesia while providing sufficient analgesia for surgical noxious stimuli.
comparison of total used opioid
1,269 studies on the registry are indexed under Agnosia; 524 are open to participants now.
This study's planned enrollment of 60 is below the median of 75 across 1,089 interventional studies indexed under Agnosia.
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Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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Exclusion Criteria:
A group of participants who receive remifentanil infusion under pupillometry monitoring.
Device: Pupillometry
A group of participants who receive remifentanil infusion without pupillometry monitoring; their analgesic dose is mainly determined via hemodyamic change.
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.
remifentanil total dose in microgram
Remifentanil total dose divided by anesthesia time (minute) and patient weight (kg).
Time frame: from beginning of anesthesia to the end of the anesthesia
FLACC score
FLACC score (a pain evaluation method for children who cannot express their severity of pain verbally) right after post-anesthesia care unit arrival.
Time frame: Arrival at the post-anesthesia care unit
Adjusted analgesic dose after anesthesia
Total dose of analgesics (NSAIDs and opioids) delivered to the patient since the end of the anesthesia, until 24 hours after the end of anesthesia
Time frame: 24 hours after the end of anesthesia
Emergence time
Time between the end of the surgery and extubation
Time frame: Intraoperative
Incidence of rescue therapy
Incidence of vasopressor/inotropics/anticholinergics/fluid/vasodilators administered, due to moderate to severe hemodynamic change
Time frame: Intraoperative
Plan to share: No
This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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