An International, Multi-center, Randomized, Controlled Trial Evaluating The Effect of Xenon on Post-operative Delirium in Elderly Patients Undergoing Hip Fracture Surgery

Air Liquide Santé International13 sites in 6 countries256 target enrollmentSeptember 2010

ConditionsDelirium

InterventionsXenon Sevoflurane

DrugsXenon Sevoflurane

Overview

Phase: Phase 2
Intervention: Xenon
Conditions: Delirium
Sponsor: Air Liquide Santé International
Enrollment: 256
Locations: 13
Primary Endpoint: Post Operative Delirium diagnosed with the Confusion Assessment Method within four days post-surgery
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2010

End Date

October 2014

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Air Liquide Santé International

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Xenon

60%(1MAC)in oxygen (FiO2 = 0.35-0.45)

Intervention: Xenon

Sevoflurane

1.1-1.4% (1 MAC) in oxygen (FiO2 = 0.35-0.45) and medical air

Intervention: Sevoflurane

Outcomes

Primary Outcomes

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

Time Frame: Four days

Secondary Outcomes

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)