Pupillometry Guided Remifentanil Administration In Pediatric Anesthesia

Overview

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.

Full Title of Study: “A Prospective Randomized Study Evaluating Pupillometry Guided Remifentanil Administration in Pediatric Anesthesia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 2019

Interventions

  • Drug: Remifentanil
  • Device: Pupillometry
    • Pupillary diameter measured every 5 minutes
  • Drug: Sevoflurane
    • Administered to maintain a Bispectral Index between 40 and 60

Arms, Groups and Cohorts

  • Active Comparator: Standard practice
    • Remifentanil infusion guided by usual clinical signs (heart rate, blood pressure). Pupillometry blindly recorded. Anesthesia maintenance with sevoflurane.
  • Experimental: Pupillometry
    • Remifentanil infusion guided by changes in pupillary diameter. Anesthesia maintenance with sevoflurane.

Clinical Trial Outcome Measures

Primary Measures

  • peroperative remifentanil consumption
    • Time Frame: duration of surgery

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: 16 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Geneva
  • Provider of Information About this Clinical Study
    • Principal Investigator: Walid HABRE, Professor – University Hospital, Geneva
  • Overall Official(s)
    • Walid Habre, MD, PhD, Study Director, University of Geneva

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