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The aim of this prospective randomized study was to evaluate the impact of peroperative pupillometry monitoring on per and post-operative opioid consumption in major gynecological surgery. All patients were anesthetized with TCI of propofol and remifentanil. In the intervention group, peroperative remifentanil target was guided by pupillometry. In the other group, remifentanil was administered according to standard practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PUPILLO | Experimental | Videopupillometer Algiscan peroperative remifentanil target concentration adapted every five minutes to pupillary diameter in patients under propofol and remifentanil TCI |
|
| STANDARD | Sham Comparator | peroperative remifentanil target concentration as standard practice in patients under propofol and remifentanil TCI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Videopupillometer Algiscan | Device | pupillary diameter measurement every five minutes per-operatively |
|
| Measure | Description | Time Frame |
|---|---|---|
| peroperative remifentanil consumption in µg/kg/min | duration of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| post-operative morphine requirements in mg/kg | includes initial morphine titration and subsequent PCA use | 24 hours |
| peroperative propofol consumption in mg/kg/h | duration of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isabelle Constant, MD-PHD | Hôpital Armand Trousseau | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Departement d'anesthesie Hopital Armand Trousseau | Paris | 75012 | France |
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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 |
|---|---|
| D015742 | Propofol |
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Standard practice | Other | remifentanil administration left to the discretion of the anesthesiologist in charge according to standard practice |
|
| Propofol | Drug | TCI |
|
| Remifentanil | Drug | TCI |
|
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |