Xenon Inhalation During Orthopaedic Surgery in Elderly Subjects.

Anaesthesia Clinical Trial

Official title: Xenon Inhalation as Cover Sedation During Orthopaedic Surgery in Elderly Subjects Comparing the Effects of Inhaled Xenon and Intravenous Propofol

Status Completed

Clinical 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 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.

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anaesthesia
• Postoperative Cognitive Function

• NCT number: NCT00192959
• Study type: Interventional
• Source: Rigshospitalet, Denmark
• Status: Completed
• Phase: Phase 3
• Start date: March 2004
• Completion date: December 2004