Hip fracture surgery in elderly patients

• Conditions: Post-operative delirium after hip fracture surgery under general anaesthesia; MedDRA version: 16.1Level: PTClassification code 10020100Term: Hip fractureSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2009-017153-35-GB
• Lead Sponsor: AIR LIQUIDE SANTE INTERNATIONA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-17
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 256

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 256

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