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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
256
Group A: xenon 60% (55%-65%)(1 MAC) in oxygen (FiO2 = 0.35-0.45)
Group B: sevoflurane 1.1-1.4%(1 MAC) in oxygen (FiO2 = 0.35-0.45) and Medical air
UZ Leuven
Leuven, Belgium
Centre Hospitalier Universitaire de Grenoble
La Tronche, France
Centre Hospitalier Régional Universitaire de Montpellier
Montpellier, France
Post Operative Delirium diagnosed with the Confusion Assessment Method within four days post-surgery
Time frame: Four days
Post Operative Delirium diagnosed with the Confusion Assessment Method from day 5 post surgery to discharge from hospital
Time frame: About 7 days
Sequential Organ Failure Assessment from day 1 to day 4 post-surgery
Time frame: four days
Recovery Parameters
Time frame: fifteen minutes
economic parameters
Time frame: up to thirty days
Safety Parameters
Serious Adverse Events, Adverse Events, laboratory parameters
Time frame: Up to thirty days
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Paris, France
Groupe Hospitalier COCHIN
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
...and 3 more locations