Hip Fracture Surgery in Elderly Patients

Phase 2

Completed

• Conditions: Delirium
• Interventions: Drug: Xenon; Drug: Sevoflurane

• Registration Number: NCT01199276
• Lead Sponsor: Air Liquide Santé International

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-09
• Study First Submitted QC: 2010-09-09
• Study First Posted: 2010-09-10
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-24
• Last Update Posted: 2015-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 256

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xenon	Xenon	60%(1MAC)in oxygen (FiO2 = 0.35-0.45)
Sevoflurane	Sevoflurane	1.1-1.4% (1 MAC) in oxygen (FiO2 = 0.35-0.45) and medical air

Primary Outcome Measures

Name	Time	Method
Post Operative Delirium diagnosed with the Confusion Assessment Method within four days post-surgery	Four days

Secondary Outcome Measures

Name	Time	Method
Recovery Parameters	fifteen minutes
Post Operative Delirium diagnosed with the Confusion Assessment Method from day 5 post surgery to discharge from hospital	About 7 days
Sequential Organ Failure Assessment from day 1 to day 4 post-surgery	four days
economic parameters	up to thirty days
Safety Parameters	Up to thirty days	Serious Adverse Events, Adverse Events, laboratory parameters

Trial Locations

Locations (13)

UZ Leuven; 🇧🇪 Leuven, Belgium

Centre Hospitalier Universitaire de Grenoble; 🇫🇷 La Tronche, France

Centre Hospitalier Régional Universitaire de Montpellier; 🇫🇷 Montpellier, France

Groupe Hospitalier COCHIN; 🇫🇷 Paris cedex 14, France

Groupe Hospitalier La Pitié-Salpêtriere; 🇫🇷 Paris, France

CHU Pontchaillou - Université de Rennes 1; 🇫🇷 Rennes, France

Centre Hospitalier Universitaire de Toulouse; 🇫🇷 Toulouse, France

University Hospital Aachen; 🇩🇪 Aachen, Germany

. Klinik für Anästhesiologie - Universitätsklinikum Düsseldorf; 🇩🇪 Düsseldorf, Germany

Klinikum Mutterhaus Der Borromaerinnen; 🇩🇪 Trier, Germany

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