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NCT Number: NCT06793163

Diagnosis and Allergen Identification of Perioperative Anaphylaxis

Perioperative anaphylaxis may lead to fatal respiratory and/or circulatory events, yet both clinical diagnosis and management are challenging. Serum tryptase is an indicator that can provide important retrospective diagnostic value for anaphylaxis. Another key point in perioperative anaphylaxis management is to identify the allergens, and thus avoid re-exposure during later perioperative management. Skin testing is an important way to identify allergens.

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Key information

Conditions

Perioperative/Postoperative Complications Allergens Anaphylaxis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Skin Testing Tryptase

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Anorectal Hospital (Beijing Erlong Road Hospital）, Beijing, Beijing Municipality, China

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About this study

Perioperative anaphylaxis are rare, but may be fatal. The combined use of anesthetic drugs and other medications, and the additional effects of surgical procedures, make the diagnosis and differential diagnosis rather complicated. Subsequent allergy investigations and allergen identification are often difficult.

The change of tryptase levels is an important biomarker in differentiating anaphylaxis from other causes. It is recommended that, in case of any suspicion of perioperative anaphylaxis, serum samples for tryptase detection should be collected as soon as possible after the onset of symptoms and then repeated 24 h later. Skin testing including skin prick tests (SPT) and intradermal tests (IDT) is universally used in identifying allergens. Skin testing will be performed 4-6 weeks after the onset of perioperative anaphylaxis.

This prospective cohort study is designed to clarify the rate of perioperative anaphylaxis with testing serum tryptase level and to identify the underlying allergens by conducting skin testing in surgical patients with suspected perioperative anaphylaxis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 2 years or over;
  • Suspected anaphylaxis in the operating rooms, or history of suspected anaphylaxis in the operating room.

Exclusion criteria

  • Refuse to participate;
  • Other conditions that are considered unsuitable for study participation.

Treatment and study plan

Primary outcomes

  1. Incidence of severe perioperative anaphylaxis

    Time frame: On the day of surgery in the operating room

    Perioperative anaphylaxis is defined as anaphylaxis that is confirmed by clinical signs and symptoms and changes of serum tryptase level according to the World Allergy Organization Anaphylaxis Guidance 2020 and occurred in the operating room. Severe perioperative anaphylaxis indicates grade 3 or above according to the World Allergy Organization systemic allergic reaction grading system. The incidence is calculated as the number of cases with severe perioperative anaphylaxis divided by the total number of cases who undergo surgery in the operating room during the study period.

Secondary outcomes

  1. Diagnostic rate of anaphylaxis in patients with suspected perioperative anaphylaxis.

    Time frame: On the day of surgery in the operating room

    Perioperative anaphylaxis is defined as anaphylaxis that is confirmed by clinical signs and symptoms and changes of serum tryptase level according to the World Allergy Organization Anaphylaxis Guidance 2020 and occurred in the operating room.

    The rate is calculated as the number of cases with confirmed anaphylaxis divided by the total number of cases with suspected anaphylaxis in the operating room during the study period.

  2. Incidence of perioperative anaphylaxis

    Time frame: On the day of surgery in the operating room

    Perioperative anaphylaxis is defined as anaphylaxis that is confirmed by clinical signs and symptoms and changes of serum tryptase level according to the World Allergy Organization Anaphylaxis Guidance 2020 and occurred in the operating room. The incidence is calculated as the number of cases with any grade perioperative anaphylaxis divided by the total number of cases who undergo surgery in the operating room during the study period.

  3. Allergen detection in patients with perioperative anaphlaxis

    Time frame: At least 4-6 weeks after the confirmed perioperative anaphylaxis

    Allergen is detected with skin testing in patients with confirmed perioperative anaphylaxis. Skin testing will be performed at least 4-6 weeks after the confirmed anaphylaxis.

Other outcomes

  1. Rate of surgical suspension due to suspected perioperative anaphylaxis.

    Time frame: On the day of surgery suspected perioperative anaphylaxis

    The rate is calculated as the number of patients with surgical suspension due to suspected perioperative anaphylaxis divided by the total number of patients with suspected/confirmed perioperative anaphylaxis in the operating room during the study period.

  2. Rate of unplanned ICU admission due to suspected perioperative anaphylaxis

    Time frame: Within 24 hours of suspected perioperative anaphylaxis

    The rate is calculated as the number of patients with unplanned ICU admission due to suspected perioperative anaphylaxis divided by the total number of patients with suspected/confirmed perioperative anaphylaxis in the operating room during the study period.

  3. Rate of recurrence of perioperative anaphylaxis

    Time frame: On the day of surgery in the operating room

    Perioperative anaphylaxis is defined as anaphylaxis that is confirmed by clinical signs and symptoms and changes of serum tryptase level according to the World Allergy Organization Anaphylaxis Guidance 2020 and occurred in the operating room. The rate is calculated as the number of patients with recurrence of suspected perioperative anaphylaxis divided by the total number of patients with confirmed perioperative anaphylaxis in the operating room during the study period.

Study contacts

Contact information is provided by the study sponsor or research team.

Dong-Xin Wang, MD, PhD

CONTACT

[email protected]

86-10-83572784

Ya-Wei Li, MD

CONTACT

[email protected]

86-10-83572460

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

Diagnosis and Allergen Identification of Perioperative Anaphylaxis: a Multicenter Prospective Cohort Study

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 27, 2025
Registry last updated
Jun 18, 2026

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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