NCT00192959

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2004

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
Last Updated

September 19, 2005

Status Verified

June 1, 2005

First QC Date

September 12, 2005

Last Update Submit

September 16, 2005

Conditions

AnaesthesiaPostoperative Cognitive Function

Keywords

AnaesthesiaSurgeryPostoperativeNeuropsychological test

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

  • Secondary endpoints:-

  • Vital signs

  • Side effects

Interventions

Xenon vs propofolDRUG

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Study Officials

  • Lars S Rasmussen, MD PhD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

March 1, 2004

Study Completion

December 1, 2004

Last Updated

September 19, 2005

Record last verified: 2005-06

Locations

DK(1)