Delirium
Conditions
Keywords
Delirium, Hip Fracture, Elderly
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.
Interventions
DRUGXenon
Group A: xenon 60% (55%-65%)(1 MAC) in oxygen (FiO2 = 0.35-0.45)
DRUGSevoflurane
Group B: sevoflurane 1.1-1.4%(1 MAC) in oxygen (FiO2 = 0.35-0.45) and Medical air
Sponsors
OptumInsight
Air Liquide Santé International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post Operative Delirium diagnosed with the Confusion Assessment Method within four days post-surgery | Four days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Recovery Parameters | fifteen minutes | — |
| economic parameters | up to thirty days | — |
| Safety Parameters | Up to thirty days | Serious Adverse Events, Adverse Events, laboratory parameters |
Countries
Belgium, France, Germany, Italy, Spain, United Kingdom
Outcome results
None listed