NCT04194788
Completed
Not Applicable
Prospective Observational Pilot Study on Olfaction Alterations That Occur in Spine Patients After Surgery
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio1 site in 1 country50 target enrollmentApril 29, 2021
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Orthopedic Disorder of Spine
- Sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Changes in olfaction threshold
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This observational prospective study evaluates perioperative olfaction alterations, comprising changes in threshold value, discrimination and identification, which occur in spine patients. The single group is subjected to a preoperative and a postoperative assessment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males or females
- •Caucasian race
- •Between 50 and 85 years of age
- •Candidates to spine surgery
- •Acceptance and signing of informed consent
Exclusion Criteria
- •Past or present cancer
- •Heart failure
- •Kidney failure (III-IV)
- •Past or present neuropsychiatric disorders
- •Heavy smokers (over/equal 3 cigarettes per day)
- •Smell disorders
- •Allergies to the respiratory system
Outcomes
Primary Outcomes
Changes in olfaction threshold
Time Frame: Day before surgery and first day after surgery
Changes in the olfaction threshold evaluated with a series of solutions having different concentrations of aromas
Study Sites (1)
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