Pupillometry Guided Remifentanil Administration In Pediatric Anesthesia

Study Overview
=================
Brief Summary
-----------------
The aim of this prospective randomized study is to evaluate the impact of peroperative pupillometry monitoring on per and post-operative opioid consumption in pediatric anesthesia. All patients are anesthetized with sevoflurane and remifentanil. In the intervention group, peroperative remifentanil infusion rate is guided by pupillometry. In the other group, remifentanil infusion rate is guided according to hemodynamic data.

Official Title
-----------------
A Prospective Randomized Study Evaluating Pupillometry Guided Remifentanil Administration in Pediatric Anesthesia

Conditions
-----------------
Anesthesia, Pain, Child

Intervention / Treatment
-----------------
* Drug: Remifentanil
* Device: Pupillometry
* Drug: Sevoflurane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children scheduled for a surgery lasting more than 90 minutes. Exclusion Criteria: Contraindication to sevoflurane, to remifentanil or to morphine. Peripheral or central nerve block during and after surgery. Ophthalmological disease. Peroperative position with no acess to the head. Chronic use of medication interfering with pupillary diameter. Ambulatory surgery

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard practice<br>Remifentanil infusion guided by usual clinical signs (heart rate, blood pressure). Pupillometry blindly recorded. Anesthesia maintenance with sevoflurane. | Drug: Remifentanil<br> <br> Drug: Sevoflurane<br>* Administered to maintain a Bispectral Index between 40 and 60<br>|
| Experimental: Pupillometry<br>Remifentanil infusion guided by changes in pupillary diameter. Anesthesia maintenance with sevoflurane. | Drug: Remifentanil<br> <br> Device: Pupillometry<br>* Pupillary diameter measured every 5 minutes<br>Drug: Sevoflurane<br>* Administered to maintain a Bispectral Index between 40 and 60<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peroperative remifentanil consumption |  | duration of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine consumption |  | during the 24 hour post operative period | 
| Incidence of morphine side effects | Sedation, nausea, vomiting, pruritus, urinary retention | during the 24 hour post operative period | 
| Pain scoring (verbal numerical scale) |  | during the 24 hour post operative period | 
| Pain scoring (questionnaire) |  | one month post-operatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intraoperative Neurophysiological Monitoring, Reflex, Pupillary, remifentanil