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Hypersensitivity Reactions During Anesthesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04125420
Recruitment Status : Recruiting
First Posted : October 14, 2019
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Alexei Gonzalez-Estrada, MD, Mayo Clinic

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

Condition or disease
Allergy

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Study Type : Observational
Estimated Enrollment : 20000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hypersensitivity Reactions During Anesthesia: A Single Center Study
Actual Study Start Date : April 3, 2018
Estimated Primary Completion Date : March 25, 2020
Estimated Study Completion Date : March 25, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy




Primary Outcome Measures :
  1. Incidence. [ Time Frame: 2-3 years ]
    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


Secondary Outcome Measures :
  1. Risk factors [ Time Frame: 2-3 years ]
    Risk factors; including female gender, prior reactions during surgery, sensitization to a previous agent used during surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adults undergoing surgery at Mayo Clinic Florida
Criteria

Inclusion Criteria:

  • Patients over age 18 undergoing surgery at Mayo Clinic Florida

Exclusion Criteria:

  • Minors under age 18
  • Unable to consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04125420


Locations
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United States, Florida
Mayo Clinic Recruiting
Jacksonville, Florida, United States, 32224
Contact: Ismael Carrillo-Martin, MD    904-953-2451    Carrillo-Martin.Ismael@mayo.edu   
Principal Investigator: Alexei Gonzalez Estada, MD         
Mayo Clinic Recruiting
Jacksonville, Florida, United States, 32224
Contact: Alexei Gonzalez-Estrada, MD    904-953-2451    gonzalez.alexei@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Alexei Gonzalez Estrada, MD Mayo Clinic

Additional Information:
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Responsible Party: Alexei Gonzalez-Estrada, MD, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04125420    
Other Study ID Numbers: 18-001390
First Posted: October 14, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs