Pupillometry-guided Remifentanil Infusion Versus Conventional Administration in Children

Study Overview
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Brief Summary
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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.

Detailed Description
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comparison of total used opioid

Official Title
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Comparison of Remifentanil Consumption in Pupillometry-guided Versus Conventional Administration in Pediatric Surgery: a Prospective, Randomized Controlled Trial

Conditions
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Opioid Use

Intervention / Treatment
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* Device: Pupillometry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric patients who are at 3 to 6 years of age, scheduled to undergo elective surgery with estimated time of operation 2 hours or longer, under general anesthesia 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: History of hypersensitivity/allergic reaction to the drugs which are used in general anesthesia 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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: 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)
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pupillometry group<br>A group of participants who receive remifentanil infusion under pupillometry monitoring. | Device: Pupillometry<br>* 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.<br>|
| No Intervention: Conventional group<br>A group of participants who receive remifentanil infusion without pupillometry monitoring; their analgesic dose is mainly determined via hemodyamic change. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pupil dilatory reflex, Remifentanil, Analgesia