Xenon Inhalation During Orthopaedic Surgery in Elderly Subjects.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00192959
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : September 19, 2005
Linde AG
Information provided by:
Rigshospitalet, Denmark

Brief Summary:
The primary objective was to explore the feasibility of inhaled xenon for sedation in terms of its effect on postoperative cognitive function in elderly, in comparison with the postoperative cognitive function found after IV propofol sedation in the same population.The secondary objectives were designed to assess the feasibility of xenon sedation in terms of its effects on different neuropsycho-logical test variables, vital signs, sedation levels and safety in elderly orthopaedic subjects.

Condition or disease Intervention/treatment Phase
Anaesthesia Postoperative Cognitive Function Drug: Xenon vs propofol Phase 3

Detailed Description:
Primary endpoint: - The primary efficacy parameter was a combined score based on the seven variables derived from four validated neuropsychological tests of cognitive function; Visual Verbal Learning test, Concept Shifting test, Stroop Color Word Interference test and Letter Digit Coding test. The parameter was used for comparing changes in test results between the screening and first postoperative follow-up testing for the treatment groups.Secondary endpoints:- Cognitive performance changes from baseline to the first post-operative follow-up judged separately for each of the seven variables from the changes in the test results.- Cognitive performance changes from baseline to the second postoperative follow-up judged separately and globally for each of the seven variables from the changes in test results.- Adequacy of ventilation (respiratory rate and pulse oximetry)- Adequacy of xenon sedation by monitoring depth of unconsciousness, signs of airway irritation, need for additional sedatives, time to recovery from anaesthesia. - Technical performance of xenon delivery device

Study Type : Interventional  (Clinical Trial)
Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Xenon Inhalation as Cover Sedation During Orthopaedic Surgery in Elderly Subjects Comparing the Effects of Inhaled Xenon and Intravenous Propofol
Study Start Date : March 2004
Study Completion Date : December 2004

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U.S. FDA Resources

Primary Outcome Measures :
  1. Primary endpoint: -cognitive function; Visual Verbal Learning test, Concept Shifting test, Stroop Color Word Interfer

Secondary Outcome Measures :
  1. Secondary endpoints:-
  2. Vital signs
  3. Side effects

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female subjects ≥ 60 years of age.
  • American Soc. of Anaesthesiologists Physical Status Classification (ASA) I-III status [27]
  • Referred for elective orthopaedic knee surgery with an anticipated duration of > 45 min
  • Expected to remain in hospital for at least 3 days
  • Expected to be able to comply with the study protocol throughout the study period
  • Mini Mental State Examination (MMSE) score > 23
  • Informed consent given

Exclusion Criteria:

  • Disease of the CNS (infectious, metabolic, tumours, dementia, epilepsy, major psychiatric disease, confusion/ delirium according to Diagnostic & Statistical Manual of Mental Disorders (DSM) IV criteria)
  • Contradiction for spinal anaesthesia
  • Contradiction for laryngeal mask
  • Regular use of tranquillisers, or antidepressants, if prescribed by psychiatrist for psychosis or depression
  • Undergone neuropsychological testing within the last year
  • Unable to follow study procedures, illiteracy, or poor comprehension of the language used in the psychometric tests
  • Severe visual or auditory disorder
  • Alcoholism or drug abuse

CNS disease BMI > 35 Inab

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00192959

Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Linde AG
Principal Investigator: Lars S Rasmussen, MD PhD Rigshospitalet, Denmark Identifier: NCT00192959     History of Changes
Other Study ID Numbers: KF 02-065/03
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: September 19, 2005
Last Verified: June 2005

Keywords provided by Rigshospitalet, Denmark:
Neuropsychological test

Additional relevant MeSH terms:
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics, Inhalation