Pupillometry Guided Remifentanil Administration In Pediatric Anesthesia

April 16, 2024 updated by: Walid HABRE, University Hospital, Geneva

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1206
        • Geneva Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 16 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard practice

Remifentanil infusion guided by usual clinical signs (heart rate, blood pressure).

Pupillometry blindly recorded. Anesthesia maintenance with sevoflurane.
Drug: Remifentanil
Drug: Sevoflurane
Administered to maintain a Bispectral Index between 40 and 60
Experimental: Pupillometry
Remifentanil infusion guided by changes in pupillary diameter. Anesthesia maintenance with sevoflurane.
Drug: Remifentanil
Drug: Sevoflurane
Administered to maintain a Bispectral Index between 40 and 60
Device: Pupillometry
Pupillary diameter measured every 5 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
peroperative remifentanil consumption
Time Frame: duration of surgery
duration of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphine consumption
Time Frame: during the 24 hour post operative period
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
during the 24 hour post operative period
Pain scoring (verbal numerical scale)
Time Frame: during the 24 hour post operative period
during the 24 hour post operative period
Pain scoring (questionnaire)
Time Frame: one month post-operatively
one month post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Investigators

  • Study Director: Walid Habre, MD, PhD, University of Geneva

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Estimated)

December 1, 2022

Study Registration Dates

First Submitted

January 19, 2016

First Submitted That Met QC Criteria

February 11, 2016

First Posted (Estimated)

February 17, 2016

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pupilloped

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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