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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00192959
• Other study ID #: KF 02-065/03
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: September 16, 2005
• Start date: March 2004
• Est. completion date: December 2004

Study information

• Verified date: June 2005
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

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

Intervention

Drug:
• Xenon vs propofol

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Linde AG

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary endpoint: -cognitive function; Visual Verbal Learning test, Concept Shifting test, Stroop Color Word Interfer
Secondary	Secondary endpoints:-
Secondary	Vital signs
Secondary	Side effects