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OpenTrials
Completed

NCT Number: NCT04194788

Olfaction Changes in Patients Undergoing Spine 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.

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Key information

Conditions

Orthopedic Disorder of Spine Nervous System Diseases Neurologic Manifestations Olfaction Disorders Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Smell Disorder

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Istituto Ortopedico Galeazzi

Milan, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 11, 2019
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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