Clinical trial

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

Name

Pupilloped

Description

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.

Trial arms

Trial start

2016-04-01

Estimated PCD

2016-11-01

Trial end

2022-12-01

Status

Withdrawn

Treatment

Remifentanil

Arms:

Pupillometry, Standard practice

Pupillometry

Pupillary diameter measured every 5 minutes

Arms:

Pupillometry

Sevoflurane

Administered to maintain a Bispectral Index between 40 and 60

Arms:

Pupillometry, Standard practice

Primary endpoint

peroperative remifentanil consumption

duration of surgery

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

Updated at

2024-04-18

1 organization

2 products

3 indications

Organization

University Hospital Geneva

Product

Indication

Indication

Indication

Product