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NCT04194788 Clinical Trial

Olfaction Changes in Patients Undergoing Spine Surgery

Orthopedic Disorder of Spine Clinical Trial

Official title:
Prospective Observational Pilot Study on Olfaction Alterations That Occur in Spine Patients After Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04194788
Other study ID # TASTEODOR (PI: M Briguglio)
Secondary ID L4133
Status Completed
Phase
First received
Last updated
Start date April 29, 2021
Est. completion date July 27, 2021

Study information
Verified date May 2023
Source Istituto Ortopedico Galeazzi
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date July 27, 2021
Est. primary completion date July 27, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 85 Years
Eligibility 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 - Rhinitis - Allergies to the respiratory system

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy IRCCS Istituto Ortopedico Galeazzi Milan

Sponsors (1)
Lead Sponsor Collaborator
Istituto Ortopedico Galeazzi

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in olfaction threshold Changes in the olfaction threshold evaluated with a series of solutions having different concentrations of aromas Day before surgery and first day after surgery
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