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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pupillometry group | Experimental | A group of participants who receive remifentanil infusion under pupillometry monitoring. |
|
| Conventional group | No Intervention | A group of participants who receive remifentanil infusion without pupillometry monitoring; their analgesic dose is mainly determined via hemodyamic change. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pupillometry | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| remifentanil total dose in microgram | Remifentanil total dose divided by anesthesia time (minute) and patient weight (kg). | 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. | 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 | 24 hours after the end of anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Emergence time | Time between the end of the surgery and extubation | Intraoperative |
| Incidence of rescue therapy | Incidence of vasopressor/inotropics/anticholinergics/fluid/vasodilators administered, due to moderate to severe hemodynamic change |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hee-Soo Kim, M.D., Ph.D. | Contact | +82-2-2072-3664 | dami0605@snu.ac.kr | |
| Sang-Whan Ji | Contact | +82-2-2072-3661 | taepoongshin@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hee-Soo Kim, M.D., Ph.D. | Dept. of Anesthesiology and Pain Medicine, Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29671874 | Result | 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. | |
| 28719527 | Result | 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. |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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Interventional group: remifentanil infusion under pupillometry monitoring. Control group: remifentanil infusion without pupillometry monitoring (remifentanil dose is determined by conventional method, i. e., hemodynamic change probably related to noxious stimuli)
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Participant does not know in which of the groups he/she is allocated. Only a care provider (an attending anesthesiologist who is responsible for the patient's anesthesia) knows the group which the patient belongs to.
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.
|
| Intraoperative |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |