Status:
COMPLETED
Xenon Inhalation During Orthopaedic Surgery in Elderly Subjects.
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
Linde AG
Conditions:
Anaesthesia
Postoperative Cognitive Function
Eligibility:
All Genders
60+ years
Phase:
PHASE3
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2004
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00192959
Start Date
March 1 2004
End Date
December 1 2004
Last Update
September 19 2005
Active Locations (1)
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1
Rigshospitalet
Copenhagen, Denmark, 2100