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| Name | Class |
|---|---|
| OptumInsight | UNKNOWN |
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The objective of this study is to evaluate the incidence of Post-Operative Delirium (POD), diagnosed with the Confusion Assessment Method (CAM), in elderly patients undergoing hip fracture surgery under general anaesthesia with xenon or sevoflurane, for a period of four days post-surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xenon | Experimental | 60%(1MAC)in oxygen (FiO2 = 0.35-0.45) |
|
| Sevoflurane | Active Comparator | 1.1-1.4% (1 MAC) in oxygen (FiO2 = 0.35-0.45) and medical air |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xenon | Drug | Group A: xenon 60% (55%-65%)(1 MAC) in oxygen (FiO2 = 0.35-0.45) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post Operative Delirium diagnosed with the Confusion Assessment Method within four days post-surgery | Four days |
| Measure | Description | Time Frame |
|---|---|---|
| Post Operative Delirium diagnosed with the Confusion Assessment Method from day 5 post surgery to discharge from hospital | About 7 days | |
| Sequential Organ Failure Assessment from day 1 to day 4 post-surgery | four days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark COBURN, MD | University Hospital Aachen - Germany | Study Chair |
| Robert SANDERS, MD | Imperial College London - UK | Study Chair |
| Rolf ROSSAINT, MD | University Hospital Aachen - Germany | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Leuven | 3000 | Belgium | |||
| Centre Hospitalier Universitaire de Grenoble |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29397119 | Derived | Coburn M, Sanders RD, Maze M, Nguyen-Pascal ML, Rex S, Garrigues B, Carbonell JA, Garcia-Perez ML, Stevanovic A, Kienbaum P, Neukirchen M, Schaefer MS, Borghi B, van Oven H, Tognu A, Al Tmimi L, Eyrolle L, Langeron O, Capdevila X, Arnold GM, Schaller M, Rossaint R; HIPELD Study Investigators. The hip fracture surgery in elderly patients (HIPELD) study to evaluate xenon anaesthesia for the prevention of postoperative delirium: a multicentre, randomized clinical trial. Br J Anaesth. 2018 Jan;120(1):127-137. doi: 10.1016/j.bja.2017.11.015. Epub 2017 Nov 21. | |
| 23016882 |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D014978 | Xenon |
| D000077149 | Sevoflurane |
| ID | Term |
|---|---|
| D005741 | Noble Gases |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
| D008738 |
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| Sevoflurane | Drug | Group B: sevoflurane 1.1-1.4%(1 MAC) in oxygen (FiO2 = 0.35-0.45) and Medical air |
|
| Recovery Parameters | fifteen minutes |
| economic parameters | up to thirty days |
| Safety Parameters | Serious Adverse Events, Adverse Events, laboratory parameters | Up to thirty days |
| La Tronche |
| 38700 |
| France |
| Centre Hospitalier Régional Universitaire de Montpellier | Montpellier | 34295 | France |
| Groupe Hospitalier La Pitié-Salpêtriere | Paris | 75651 | France |
| Groupe Hospitalier COCHIN | Paris | 75979 | France |
| CHU Pontchaillou - Université de Rennes 1 | Rennes | 35033 | France |
| Centre Hospitalier Universitaire de Toulouse | Toulouse | 31059 | France |
| University Hospital Aachen | Aachen | 52074 | Germany |
| . Klinik für Anästhesiologie - Universitätsklinikum Düsseldorf | Düsseldorf | 40225 | Germany |
| Klinikum Mutterhaus Der Borromaerinnen | Trier | 54290 | Germany |
| IRCCS Rizzoli Orthopaedic Institute | Bologna | 40136 | Italy |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Imperial College NHS Trust | London | W2 1NY | United Kingdom |
| Derived |
| Coburn M, Sanders RD, Maze M, Rossaint R; HIPELD Investigators. The Hip Fracture Surgery in Elderly Patients (HIPELD) study: protocol for a randomized, multicenter controlled trial evaluating the effect of xenon on postoperative delirium in older patients undergoing hip fracture surgery. Trials. 2012 Sep 27;13:180. doi: 10.1186/1745-6215-13-180. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
| Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |