Hip Fracture Surgery in Elderly Patients (HIPELD)

Air Liquide

Status and phase

Completed

Phase 2

Conditions

Delirium

Treatments

Drug: Xenon

Drug: Sevoflurane

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT01199276

ALMED-08-C2-020

Details and patient eligibility

About

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.

Enrollment

256 patients

Sex

All

Ages

75+ years old

Volunteers

No Healthy Volunteers

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