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Pupillometry Guided Remifentanil Administration In Pediatric Anesthesia

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02683837
Enrollment
0
Registered
2016-02-17
Start date
2016-04-30
Completion date
2022-12-31
Last updated
2024-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Child, Pain

Keywords

Intraoperative Neurophysiological Monitoring, Reflex, Pupillary, remifentanil

Brief summary

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.

Interventions

DRUGRemifentanil
DEVICEPupillometry

Pupillary diameter measured every 5 minutes

DRUGSevoflurane

Administered to maintain a Bispectral Index between 40 and 60

Sponsors

University Hospital, Geneva
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
2 Years to 16 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
peroperative remifentanil consumptionduration of surgery

Secondary

MeasureTime frameDescription
Morphine consumptionduring the 24 hour post operative period
Incidence of morphine side effectsduring the 24 hour post operative periodSedation, nausea, vomiting, pruritus, urinary retention
Pain scoring (verbal numerical scale)during the 24 hour post operative period
Pain scoring (questionnaire)one month post-operatively

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026