Pupillometry Guided Remifentanil Administration In Pediatric Anesthesia

NCT ID: NCT02683837

Last Updated: 2024-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anesthesia Pain Child

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard practice

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

Pupillometry blindly recorded. Anesthesia maintenance with sevoflurane.

Group Type ACTIVE_COMPARATOR

Remifentanil

Intervention Type DRUG

Sevoflurane

Intervention Type DRUG

Administered to maintain a Bispectral Index between 40 and 60

Pupillometry

Remifentanil infusion guided by changes in pupillary diameter. Anesthesia maintenance with sevoflurane.

Group Type EXPERIMENTAL

Remifentanil

Intervention Type DRUG

Pupillometry

Intervention Type DEVICE

Pupillary diameter measured every 5 minutes

Sevoflurane

Intervention Type DRUG

Administered to maintain a Bispectral Index between 40 and 60

Interventions

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Remifentanil

Intervention Type DRUG

Pupillometry

Pupillary diameter measured every 5 minutes

Intervention Type DEVICE

Sevoflurane

Administered to maintain a Bispectral Index between 40 and 60

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

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Walid HABRE

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Walid Habre, MD, PhD

Role: STUDY_DIRECTOR

University of Geneva

Locations

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Geneva Children's Hospital

Geneva, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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Pupilloped

Identifier Type: -

Identifier Source: org_study_id

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