Skip to main content
Clinical Trials/NCT04194788
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.

Registry
clinicaltrials.gov
Start Date
April 29, 2021
End Date
July 27, 2021
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Responsible Party
Sponsor

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)

Loading locations...

Similar Trials