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Xenon Inhalation During Orthopaedic Surgery in Elderly Subjects.

This study has been completed.
Sponsor:
Collaborator:
Linde AG
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00192959
First received: September 12, 2005
Last updated: September 16, 2005
Last verified: June 2005
History of Changes
  Purpose

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.


Condition Intervention Phase
Anaesthesia
Postoperative Cognitive Function
 Drug: Xenon vs propofol
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Xenon Inhalation as Cover Sedation During Orthopaedic Surgery in Elderly Subjects Comparing the Effects of Inhaled Xenon and Intravenous Propofol

Resource links provided by NLM:

Drug Information available for: Propofol
U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Primary endpoint: -cognitive function; Visual Verbal Learning test, Concept Shifting test, Stroop Color Word Interfer

Secondary Outcome Measures:
  • Secondary endpoints:-
  • Vital signs
  • Side effects

Estimated Enrollment: 44
Study Start Date: March 2004
Estimated Study Completion Date: December 2004
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 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

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00192959

Locations
Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Linde AG
Investigators
Principal Investigator: Lars S Rasmussen, MD PhD Rigshospitalet, Denmark
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00192959     History of Changes
Other Study ID Numbers: KF 02-065/03
Study First Received: September 12, 2005
Last Updated: September 16, 2005
Health Authority: Denmark: National Board of Health

Keywords provided by Rigshospitalet, Denmark:
Anaesthesia
Surgery
Postoperative
Neuropsychological test

Additional relevant MeSH terms:
Propofol
Xenon
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Anesthetics, Inhalation

ClinicalTrials.gov processed this record on June 17, 2013