E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Post-operative delirium after hip fracture surgery under general anaesthesia |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020100 |
E.1.2 | Term | Hip fracture |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
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
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
|
|
E.4 | Principal 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.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Post-operative Delirium, diagnosed with the CAM, at least once within four days post surgery. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
|
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 2 |