An international, multi-center, randomized, controlled trial evaluating the effect of xenon on post-operative delirium in elderly patients undergoing hip fracture surgery. - Hip fracture surgery in elderly patients

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 268

Inclusion Criteria

- Elderly patient (= 75 years).
- Patients 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Patient suffering of multiple fractures, pelvic fractures proximal, pathological fractures, femur fractures (ie fracture of the middle and 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.
- Patients who cannot complete the pre-operative mental tests of this current clinical trial
- Patients with Mini-Mental State Examination (MMSE) score < 24 at selection.
- Contra-indication (serious illness or medical conditions) for general anaesthesia .
- Known allergy or hypersensitivity to any drugs administered during the current clinical trial.
- Previous participation in this current 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.
- 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): Post-operative Delirium, diagnosed with the CAM, at least once within four days post surgery.;Secondary Objective: 1. To compare the incidence of POD between xenon group and sevoflurane group.<br>2. To evaluate the incidence of POD from Day 5 post-surgery until discharge from hospital<br>3. To determine the time to first POD diagnosis<br>4. To evaluate the duration of POD<br>5. To evaluate the evolution of the physiological status of the patients in the post-operative period<br>6. To evaluate the recovery parameters<br>7. To collect preliminary data to evaluate the economical impact of POD in the post-operative period<br>8. To collect safety data<br><br>;Main Objective: The primary objective 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.

Secondary Outcome Measures

Name	Time	Method