Hypersensitivity Reactions During Anesthesia

Hypersensitivity Reactions During Anesthesia: A Single Center Study

Researchers are trying to study the natural history of allergic reactions during anesthesia and its causes and risk factors.

Study Overview

• Status: Completed
• Conditions: Allergy

• Study Type: Observational
• Enrollment (Actual): 940

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults undergoing surgery at Mayo Clinic Florida

Description

Inclusion Criteria:

• Patients over age 18 undergoing surgery at Mayo Clinic Florida

Exclusion Criteria:

• Minors under age 18
• Unable to consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence.	Current estimates are between 1:400 to 1:10,000 surgeries mostly based on retrospective reviews. We will report incidence based on numbers of event/number of surgeries	2-3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk factors	Risk factors; including female gender, prior reactions during surgery, sensitization to a previous agent used during surgery	2-3 years

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Alexei Gonzalez Estrada, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2018
• Primary Completion (Actual): February 1, 2022
• Study Completion (Actual): February 1, 2022

Study Registration Dates

• First Submitted: July 28, 2019
• First Submitted That Met QC Criteria: October 11, 2019
• First Posted (Actual): October 14, 2019

Study Record Updates

• Last Update Posted (Actual): February 2, 2022
• Last Update Submitted That Met QC Criteria: February 1, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: 18-001390

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No