Hip Fracture Surgery in Elderly Patients
- Registration Number
- NCT01199276
- Lead Sponsor
- Air Liquide Santé International
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 256
- Elderly patient (≥ 75 years)
- Patient with planned hip fracture surgery within 48 hours after the hip fracture
- Patient willing and able to complete the requirements of this study including the signature of the written informed consent
- Patient suffering from multiple fractures, pelvic fractures proximal, pathological fractures, femur fractures (i.e., fractures of the middle or distal femur)
- Disabling neuropsychiatric disorders (severe dementia, Alzheimer's disease, schizophrenia, depression)
- Brain trauma within 12 months prior to selection, history of stroke with residuals
- Patient suffering from delirium (CAM diagnosis) at selection
- Patient who cannot complete the pre-operative mental tests (CAM and/or MMSE) of this clinical trial
- Patient with Mini-Mental State Examination (MMSE) score < 24 at selection
- Patient known to susceptible to malignant hyperthermia
- Patient with elevated intra-cranial pressure
- Patient with a risk of high oxygen demand
- Patient with recent or ongoing myocardial infarction / damage
- Patient with severe cardiac failure, or patient with severe impaired left ventricular systolic function
- Patient with known severe lung and/or airway disease, or severe chronic respiratory insufficiency, or a sustained homecare oxygen therapy
- Contra-indication (serious illness or medical conditions) for general anaesthesia
- Known allergy or hypersensitivity to any drugs administered during this clinical trial
- Previous participation in this clinical trial
- Participation in another clinical trial within 4 weeks prior to selection
- History of alcohol or drug abuse or psychiatric disorders which would impair the understanding of the necessary information or render medically or legally unable to give written informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Xenon Xenon 60%(1MAC)in oxygen (FiO2 = 0.35-0.45) Sevoflurane Sevoflurane 1.1-1.4% (1 MAC) in oxygen (FiO2 = 0.35-0.45) and medical air
- Primary Outcome Measures
Name Time Method Post Operative Delirium diagnosed with the Confusion Assessment Method within four days post-surgery Four days
- Secondary Outcome Measures
Name Time Method Recovery Parameters fifteen minutes 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 economic parameters up to thirty days Safety Parameters Up to thirty days Serious Adverse Events, Adverse Events, laboratory parameters
Trial Locations
- Locations (13)
UZ Leuven
🇧🇪Leuven, Belgium
Centre Hospitalier Universitaire de Grenoble
🇫🇷La Tronche, France
Centre Hospitalier Régional Universitaire de Montpellier
🇫🇷Montpellier, France
CHU Pontchaillou - Université de Rennes 1
🇫🇷Rennes, France
Centre Hospitalier Universitaire de Toulouse
🇫🇷Toulouse, France
Groupe Hospitalier La Pitié-Salpêtriere
🇫🇷Paris, France
Groupe Hospitalier COCHIN
🇫🇷Paris cedex 14, France
University Hospital Aachen
🇩🇪Aachen, Germany
. Klinik für Anästhesiologie - Universitätsklinikum Düsseldorf
🇩🇪Düsseldorf, Germany
Klinikum Mutterhaus Der Borromaerinnen
🇩🇪Trier, Germany
IRCCS Rizzoli Orthopaedic Institute
🇮🇹Bologna, Italy
Hospital Clinico Universitario de Valencia
🇪🇸Valencia, Spain
Imperial College NHS Trust
🇬🇧London, United Kingdom