Olfaction Changes in Patients Undergoing Spine Surgery

Completed

• Conditions: Smell Disorder; Orthopedic Disorder of Spine

• Registration Number: NCT04194788
• Lead Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2019-12-10
• Study First Posted: 2019-12-11
• Study Start: 2021-04-29
• Primary Completion: 2021-07-27
• Study Completion: 2021-07-27
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-04
• Last Update Posted: 2023-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in olfaction threshold	Day before surgery and first day after surgery	Changes in the olfaction threshold evaluated with a series of solutions having different concentrations of aromas

Trial Locations

Locations (1)

IRCCS Istituto Ortopedico Galeazzi; 🇮🇹 Milan, Italy