Post-operative delirium after hip fracture surgery under general anaesthesia MedDRA version: 12.1 Level: LLT Classification code 10020100 Term: Hip fracture
Conditions
Interventions
Trade Name: LENOXe
Product Name: xenon
Pharmaceutical Form: Inhalation gas
Product Name: sevoflurane
Pharmaceutical Form: Inhalation vapour, liquid
INN or Proposed INN: sevoflurane
Sponsors
AIR LIQUIDE SANTE INTERNATIONAL
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 2. To evaluate the incidence of POD from Day 5 post-surgery until discharge from hospital 3. To determine the time to first POD diagnosis 4. To evaluate the duration of POD 5. To evaluate the evolution of the physiological status of the patients in the post-operative period 6. To evaluate the recovery parameters 7. To collect preliminary data to evaluate the economical impact of POD in the post-operative period 8. To collect safety data ;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. | — |
Countries
Belgium, France, Germany, Italy, Spain, United Kingdom
Outcome results
None listed