Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00192959
Status:
COMPLETED
Last Update Posted:
2005-09-19
First Post:
2005-09-12
Brief Title:
Xenon Inhalation During Orthopaedic Surgery in Elderly Subjects
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Xenon Inhalation as Cover Sedation During Orthopaedic Surgery in Elderly Subjects Comparing the Effects of Inhaled Xenon and Intravenous Propofol
Status:
COMPLETED
Status Verified Date:
2005-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 populationThe 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 groupsSecondary 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None