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Principal investigator left the institution
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard practice | Active Comparator | Remifentanil infusion guided by usual clinical signs (heart rate, blood pressure). Pupillometry blindly recorded. Anesthesia maintenance with sevoflurane. |
|
| Pupillometry | Experimental | Remifentanil infusion guided by changes in pupillary diameter. Anesthesia maintenance with sevoflurane. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remifentanil | Drug |
| ||
| Pupillometry |
| Measure | Description | Time Frame |
|---|---|---|
| peroperative remifentanil consumption | duration of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Morphine consumption | during the 24 hour post operative period | |
| Incidence of morphine side effects | Sedation, nausea, vomiting, pruritus, urinary retention | during the 24 hour post operative period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Walid Habre, MD, PhD | University of Geneva, Switzerland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geneva Children's Hospital | Geneva | 1206 | Switzerland |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077208 | Remifentanil |
| D000077149 | Sevoflurane |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Device |
Pupillary diameter measured every 5 minutes |
|
| Sevoflurane | Drug | Administered to maintain a Bispectral Index between 40 and 60 |
|
| Pain scoring (verbal numerical scale) | during the 24 hour post operative period |
| Pain scoring (questionnaire) | one month post-operatively |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |