Hip Fracture Surgery in Elderly Patients

Study Overview
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Brief Summary
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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.

Official Title
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An International, Multi-center, Randomized, Controlled Trial Evaluating The Effect of Xenon on Post-operative Delirium in Elderly Patients Undergoing Hip Fracture Surgery

Conditions
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Delirium

Intervention / Treatment
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* Drug: Xenon
* Drug: Sevoflurane


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xenon<br>60%(1MAC)in oxygen (FiO2 = 0.35-0.45) | Drug: Xenon<br>* Group A: xenon 60% (55%-65%)(1 MAC) in oxygen (FiO2 = 0.35-0.45)<br>* Other names: LENOXe;|
| Active Comparator: Sevoflurane<br>1.1-1.4% (1 MAC) in oxygen (FiO2 = 0.35-0.45) and medical air | Drug: Sevoflurane<br>* Group B: sevoflurane 1.1-1.4%(1 MAC) in oxygen (FiO2 = 0.35-0.45) and Medical air<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Operative Delirium diagnosed with the Confusion Assessment Method within four days post-surgery |  | Four days | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Recovery Parameters |  | fifteen minutes | 
| economic parameters |  | up to thirty days | 
| Safety Parameters | Serious Adverse Events, Adverse Events, laboratory parameters | Up to thirty days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delirium, Hip Fracture, Elderly