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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002551-33 | EudraCT Number |
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The objective of this study is to show that, in patients undergoing carotid endarterectomy, brain damage, assessed by the determination of S100B before removing the clamp, is less severe with a balanced anesthesia consisting of remifentanil combined with Xenon (experimental arm) compared with remifentanil anesthesia associated with propofol (reference arm).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm | Experimental | Patients in this arm undergo anesthesia with Xenon. |
|
| Standard arm | Active Comparator | Patients in this arm undergo standard anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anesthesia with Xenon | Drug | Patients undergo anesthesia with xenon (remifentanil with xenon). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence/absence of S100B > 0.2 ng/ml during surgery | Presence/absence of S100 calcium binding protein B concentration after induction and before the removal of the radial arterial catheter clamp placed before induction | During surgery (expected mean time of around 120 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| S100B change relative to baseline | The change in S100 calcium binding protein B concentration before and after surgery (ng/ml) | end of surgery (expected mean of 120 minutes) |
| NSE change from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacques Ripart, MD PhD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Nîmes | Nîmes | Gard | 30029 | France |
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| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D014978 | Xenon |
| ID | Term |
|---|---|
| D000760 | Anesthesia and Analgesia |
| D005741 | Noble Gases |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
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| Standard anesthesia | Drug | Patients undergo standard anesthesia (remifentanil with propofol) |
|
The change in Neuron Specific Enolase (NSE) between a preoperative measurement and a second measurement near the end of surgery and just before clamp removal
| end of surgery (expected mean of 2 hours), just before clamp removal |
| NSE change from baseline | The change in Neuron Specific Enolase (NSE) between a preoperative measurement and a second measurement just after surgery | end of surgery (expected mean of 2 hours) |
| Change in troponine from baseline | Change in tropinine between preoperative and postoperative measurements | end of surgery (expected mean of 2 hours) |
| Change in creatinemia from baseline | Change in creatinemia between preoperative and postoperative measurements | end of surgery (expected mean of 2 hours) |
| Change in creatine clearance from baseline | Change in creatine clearance (MDRD equation) between preoperative and postoperative measurements | end of surgery (expected mean of 2 hours) |
| Change NIHSS score from baseline | Change in the National Institute of Health Stroke Score (NIHSS) between preoperative and postoperative measurements | end of surgery (expected mean of 2 hours) |
| Number of transfusions | Number of transfused red blood cell packs | During surgery (estimated mean of 120 minutes) |
| Direct costs | Direct costs (€) incurred | 2 days |
| Indirect costs | The indirect costs (€) incurred | 2 days |
| D005740 |
| Gases |