Back to resultsXenon Inhalation During Orthopaedic Surgery in Elderly Subjects.
Primary Purpose
Anaesthesia, Postoperative Cognitive Function
Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Xenon vs propofol
Sponsored by
About this trial
This is an interventional treatment trial for Anaesthesia focused on measuring Anaesthesia, Surgery, Postoperative, Neuropsychological test
Eligibility Criteria
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
Sites / Locations
- Rigshospitalet
Outcomes
Primary Outcome Measures
Primary endpoint: -cognitive function; Visual Verbal Learning test, Concept Shifting test, Stroop Color Word Interfer
Secondary Outcome Measures
Secondary endpoints:-
Vital signs
Side effects
Full Information
NCT ID
NCT00192959
First Posted
September 12, 2005
Last Updated
September 16, 2005
Sponsor
Rigshospitalet, Denmark
Collaborators
Linde AG
1. Study Identification
Unique Protocol Identification Number
NCT00192959
Brief Title
Xenon Inhalation During Orthopaedic Surgery in Elderly Subjects.
Official Title
Xenon Inhalation as Cover Sedation During Orthopaedic Surgery in Elderly Subjects Comparing the Effects of Inhaled Xenon and Intravenous Propofol
Study Type
Interventional
2. Study Status
Record Verification Date
June 2005
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Linde AG
4. Oversight
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anaesthesia, Postoperative Cognitive Function
Keywords
Anaesthesia, Surgery, Postoperative, Neuropsychological test
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
44 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Xenon vs propofol
Primary Outcome Measure Information:
Title
Primary endpoint: -cognitive function; Visual Verbal Learning test, Concept Shifting test, Stroop Color Word Interfer
Secondary Outcome Measure Information:
Title
Secondary endpoints:-
Title
Vital signs
Title
Side effects
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars S Rasmussen, MD PhD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
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Xenon Inhalation During Orthopaedic Surgery in Elderly Subjects.
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