Xenon Inhalation During Orthopaedic Surgery in Elderly Subjects.

Rigshospitalet

Status and phase

Completed

Phase 3

Conditions

Anaesthesia

Postoperative Cognitive Function

Treatments

Drug: Xenon vs propofol

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00192959

KF 02-065/03

Details and patient eligibility

About

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.

Full 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

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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