MedTrace Logo

Evaluation of the Pupil Dilation Reflex in Response to Noxious Stimulation in Anaesthetized Children. A Proof of Concept Trial

NCT03449732 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-05-18

No results posted yet for this study

Summary

After conduction a pilot study, pupillary dilation reflex (PDR) is measured in response to nociceptive stimulation perioperatively in infants, children and adolescents.

Conditions

  • Pain
  • Monitoring, Intraoperative

Interventions

DEVICE

PDR measurement

PDR measurement at two standardized times perioperatively: 1. Anesthetized subject by sevoflurane sedation until a minimum alveolar concentration (MAC) of at least 1,5 is reached 2. Administration of fentanyl 2µg/kg, in the absence of adjustments in sedation depth

Sponsors & Collaborators

  • University Hospital, Antwerp

    lead OTHER

Principal Investigators

  • Nathalie Kegels, MD · University Hospital, Antwerp

  • Vera Saldien, MD · University Hospital, Antwerp

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
28 Days
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-30
Primary Completion
2021-04-26
Completion
2021-12-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03449732 on ClinicalTrials.gov