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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017126-39 | EudraCT Number |
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Obesity is increasing in France, resulting in an increased demand for bariatric surgery. However obesity also alters physiopathological pathways and the pharmacokinetics of anesthestic agents. The investigators objective is to compare, among morbidly obese patients, the immediate and intermediary emergence kinetics after balanced anesthesia using remifentanil associated either with desflurane (reference arm) or with xenon (experimental arm).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference - desflurane | Active Comparator | The patients in this group will undergo anesthesia using remifentanil associated with desflurane. |
|
| Experimental - xenon | Experimental | The patients in this group will undergo anesthesia using remifentanil associated with xenon |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desflurane | Drug | Patients undergo anesthesia using remifentanil associated with desflurane |
|
| Measure | Description | Time Frame |
|---|---|---|
| 30 min DSST ratio | (the number of correct responses to a Digit Symbol Substitution Test [DSST] 30 minutes after surgery) / (the number of correct responses to a Digit Symbol Substitution Test the night before the surgery) | 30 minutes post-op |
| Measure | Description | Time Frame |
|---|---|---|
| 60 min DSST test | (the number of correct responses to a Digit Symbol Substitution Test 60 minutes after surgery) / (the number of correct responses to a Digit Symbol Substitution Test the night before the surgery) | 60 minutes post-op |
| 90 min DSST test |
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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 |
|---|---|---|---|---|---|---|
| CHU de Clermont Ferrand - Hôpital Estaing | Clermont-Ferrand | 63000 | France | |||
| CHRU de Lille - Hôpital Claude Huriez |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077335 | Desflurane |
| D014978 | Xenon |
| ID | Term |
|---|---|
| D005019 | Ethyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D008738 | Methyl Ethers |
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| Xenon | Drug | Patients undergo anesthesia using remifentanil associated with xenon |
|
(the number of correct responses to a Digit Symbol Substitution Test 90 minutes after surgery) / (the number of correct responses to a Digit Symbol Substitution Test the night before the surgery) |
| 90 min post-op |
| Time to Aldrete score of 10 | Aldrete JA. The post-anesthesia recovery score revisited. J. Clin. Anesth. 1995. | Immediate post-op; this outcome measures the minutes of emergence (from anesthesia) time necessary to attain an Aldrete score of 10 |
| Quality of recovery score | The score on the Quality of Recovery Scale: Myles PS, Weitkamp B, Jones K et al. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br. J. Anaesth., 2000; 84: 11-15. | Day 1 post-op |
| Lille |
| 59037 |
| France |
| CHU de Montpellier - Hôpital Saint-Eloi | Montpellier | 34295 | France |
| CHU de Nice - Hôpitaux L'Archet 1 et 2 | Nice | 06202 | France |
| CHU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | 30029 | France |
| CHU de Poitiers | Poitiers | 86021 | France |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D005741 | Noble Gases |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |