Pain Clinical Trial
Official title:
A Prospective Randomized Study Evaluating Pupillometry Guided Remifentanil Administration in Pediatric Anesthesia
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Status | Withdrawn |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 |
Verified date | April 2024 |
Source | University Hospital, Geneva |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Geneva Children's Hospital | Geneva |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Geneva |
Switzerland,
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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