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NCT02683837 Clinical Trial

Pupillometry Guided Remifentanil Administration In Pediatric Anesthesia

Pain Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02683837
Other study ID # Pupilloped
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date April 2016
Est. completion date December 2022

Study information
Verified date April 2024
Source University Hospital, Geneva
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2022
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender All
Age group 2 Years to 16 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Remifentanil

Device:
• Pupillometry
Pupillary diameter measured every 5 minutes
Drug:
• Sevoflurane
Administered to maintain a Bispectral Index between 40 and 60

Locations
Country Name City State
Switzerland Geneva Children's Hospital Geneva

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary peroperative remifentanil consumption duration of surgery
Secondary Morphine consumption during the 24 hour post operative period
Secondary Incidence of morphine side effects Sedation, nausea, vomiting, pruritus, urinary retention during the 24 hour post operative period
Secondary Pain scoring (verbal numerical scale) during the 24 hour post operative period
Secondary Pain scoring (questionnaire) one month post-operatively
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