Olfaction Changes in Patients Undergoing Spine Surgery

May 4, 2023 updated by: Istituto Ortopedico Galeazzi

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy
        • IRCCS Istituto Ortopedico Galeazzi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing spine surgery.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day before surgery and first day after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Galeazzi

Investigators

  • Principal Investigator: Matteo Briguglio, IRCCS Istituto Ortopedico Galeazzi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2021

Primary Completion (Actual)

July 27, 2021

Study Completion (Actual)

July 27, 2021

Study Registration Dates

First Submitted

December 9, 2019

First Submitted That Met QC Criteria

December 10, 2019

First Posted (Actual)

December 11, 2019

Study Record Updates

Last Update Posted (Estimate)

May 5, 2023

Last Update Submitted That Met QC Criteria

May 4, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TASTEODOR (PI: M Briguglio)
  • L4133 (Other Grant/Funding Number: Italian Ministry of Health)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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