A Phase 3 interventional study of Xenon vs propofol in Anaesthesia and Postoperative Cognitive Function, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2005-09-19.
Sponsored by Rigshospitalet, Denmark · Phase 3, Interventional, and Treatment
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
1,092 studies on the registry are indexed under Respiratory Aspiration; 216 are open to participants now.
This study's enrollment of 44 is close to the median of 42 across 881 interventional studies indexed under Respiratory Aspiration.
Browse Respiratory Aspiration studies →Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
CNS disease BMI > 35 Inab
Primary endpoint: -cognitive function; Visual Verbal Learning test, Concept Shifting test, Stroop Color Word Interfer
Secondary endpoints:-
Vital signs
Side effects
This study is completed, as verified in Jun 2005. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Rigshospitalet, Denmark