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Completed

NCT Number: NCT01199276

Hip Fracture Surgery in Elderly Patients

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.

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Key information

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UZ Leuven, Leuven, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xenon

Drug

Group A: xenon 60% (55%-65%)(1 MAC) in oxygen (FiO2 = 0.35-0.45)

Other names: LENOXe

Sevoflurane

Drug

Group B: sevoflurane 1.1-1.4%(1 MAC) in oxygen (FiO2 = 0.35-0.45) and Medical air

Primary outcomes

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

    Time frame: Four days

Secondary outcomes

  1. Post Operative Delirium diagnosed with the Confusion Assessment Method from day 5 post surgery to discharge from hospital

    Time frame: About 7 days

  2. Sequential Organ Failure Assessment from day 1 to day 4 post-surgery

    Time frame: four days

  3. Recovery Parameters

    Time frame: fifteen minutes

  4. economic parameters

    Time frame: up to thirty days

  5. Safety Parameters

    Time frame: Up to thirty days

    Serious Adverse Events, Adverse Events, laboratory parameters

Sponsors and collaborators

Lead sponsor

Air Liquide Santé International

Industry

Collaborators

  • OptumInsight

Registry information

Official study title

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

Acronym: HIPELD

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Sep 10, 2010
Registry last updated
Jul 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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