AnaesthesiaPhase 3NCT00192959
Xenon Inhalation During Orthopaedic Surgery in Elderly Subjects.
A Phase 3 study testing Xenon vs propofol in people with Anaesthesia and Postoperative Cognitive Function, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Anaesthesia, Postoperative Cognitive Function
- What is being tested?
- Xenon vs propofol
- How many people
- 44 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2004to Dec 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Severe visual or auditory disorder
- Alcoholism or drug abuse
- CNS disease BMI > 35 Inab
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Anaesthesia, Postoperative Cognitive Function
- Being tested
- Xenon vs propofol
- Keywords
- Anaesthesia, Surgery, Postoperative, Neuropsychological test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xenon vs propofolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint: -cognitive function; Visual Verbal Learning test, Concept Shifting test, Stroop Color Word Interfer
Secondary outcomes (3)
Secondary endpoints:-
Vital signs
Side effects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startMar 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnaesthesiaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 44 participants
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Linde AG
- Investigators
- Lars S Rasmussen, MD PhD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00192959
- Sponsor's protocol ID
- KF 02-065/03
- Status last verified
- Jun 2005
- First submitted
- 12 Sep 2005
- Last updated
- 19 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xenon Inhalation as Cover Sedation During Orthopaedic Surgery in Elderly Subjects Comparing the Effects of Inhaled Xenon and Intravenous Propofol
- ClinicalTrials.gov ID
- NCT00192959
- Acronym / sponsor ID
- KF 02-065/03
- Conditions
- Anaesthesia, Postoperative Cognitive Function
- Keywords
- Anaesthesia, Surgery, Postoperative, Neuropsychological test
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Linde AG
- Study start
- Mar 2004
- Study completion
- Dec 2004
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xenon vs propofol | Drug | – |
Primary outcome
Primary endpoint: -cognitive function; Visual Verbal Learning test, Concept Shifting test, Stroop Color Word Interfer
3 secondary outcomes
Secondary endpoints:-
Vital signs
Side effects
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars S Rasmussen, MD PhD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Xenon vs propofol in people with Anaesthesia and Postoperative Cognitive Function, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint: -cognitive function; Visual Verbal Learning test, Concept Shifting test, Stroop Color Word Interfer. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2005.