Xenon Inhalation During Orthopaedic Surgery in Elderly Subjects.

This study has been completed.
Sponsor:
Collaborator:
Linde AG
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00192959
First received: September 12, 2005
Last updated: September 16, 2005
Last verified: June 2005

September 12, 2005
September 16, 2005
March 2004
Not Provided
Primary endpoint: -cognitive function; Visual Verbal Learning test, Concept Shifting test, Stroop Color Word Interfer
Same as current
Complete list of historical versions of study NCT00192959 on ClinicalTrials.gov Archive Site
  • Secondary endpoints:-
  • Vital signs
  • Side effects
Same as current
Not Provided
Not Provided
 
Xenon Inhalation During Orthopaedic Surgery in Elderly Subjects.
Xenon Inhalation as Cover Sedation During Orthopaedic Surgery in Elderly Subjects Comparing the Effects of Inhaled Xenon and Intravenous Propofol

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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
  • Anaesthesia
  • Postoperative Cognitive Function
Drug: Xenon vs propofol
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
December 2004
Not Provided

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

Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00192959
KF 02-065/03
Not Provided
Not Provided
Rigshospitalet, Denmark
Linde AG
Principal Investigator: Lars S Rasmussen, MD PhD Rigshospitalet, Denmark
Rigshospitalet, Denmark
June 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP