AllergyNCT04125420
Hypersensitivity Reactions During Anesthesia
An observational study of Allergy, run by Mayo Clinic at 1 site in United States.
Trial summary
Researchers are trying to study the natural history of allergic reactions during anesthesia and its causes and risk factors. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergy
- How many people
- 940 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2018to 1 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults undergoing surgery at Mayo Clinic Florida
Who may be able to join
- Patients over age 18 undergoing surgery at Mayo Clinic Florida
Who cannot join
- Minors under age 18
- Unable to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Allergy
- Medical subject headings
- Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2-3 years
Secondary outcomes (1)
Risk factors
Risk factors; including female gender, prior reactions during surgery, sensitization to a previous agent used during surgery
Measured: 2-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2019
- Study start3 Aug 2018
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 940 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexei Gonzalez-Estrada, MD, Mayo Clinic
- Investigators
- Alexei Gonzalez Estrada, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04125420
- Sponsor's protocol ID
- 18-001390
- Status last verified
- Feb 2022
- First submitted
- 28 Jul 2019
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypersensitivity Reactions During Anesthesia: A Single Center Study
- ClinicalTrials.gov ID
- NCT04125420
- Acronym / sponsor ID
- 18-001390
- Conditions
- Allergy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 940 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 3 Aug 2018 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 14 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Researchers are trying to study the natural history of allergic reactions during anesthesia and its causes and risk factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults undergoing surgery at Mayo Clinic Florida
Key inclusion criteria (1 listed)
- Patients over age 18 undergoing surgery at Mayo Clinic Florida
Key exclusion criteria (2 listed)
- Minors under age 18
- Unable to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Risk factors
Time frame: 2-3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexei Gonzalez Estrada, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergy, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence. (time frame: 2-3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2022.