An observational study in Perioperative/Postoperative Complications, Anaphylaxis and Tryptase, sponsored by Peking University First Hospital. Recruiting at 6 sites in China. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by Peking University First Hospital · Observational
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.
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.
1,332 studies on the registry are indexed under Postoperative Complications; 311 are open to participants now.
This study's planned enrollment of 115 is below the median of 251 across 537 observational studies indexed under Postoperative Complications.
Browse Postoperative Complications studies →Peking University First Hospital is the lead sponsor of 390 studies on the registry; 186 are open to participants now.
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Patients with suspected anaphylaxis in the operating room.
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Exclusion Criteria:
Adult patients with suspected anaphylaxis in the operating rooms, or with history of suspected anaphylaxis in the operating room.
Incidence of severe perioperative anaphylaxis
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.
Time frame: On the day of surgery in the operating room
Diagnostic rate of anaphylaxis in patients with suspected perioperative anaphylaxis.
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.
Time frame: On the day of surgery in the operating room
Incidence of perioperative anaphylaxis
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.
Time frame: On the day of surgery in the operating room
Allergen detection in patients with perioperative anaphlaxis
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.
Time frame: At least 4-6 weeks after the confirmed perioperative anaphylaxis
Rate of surgical suspension due to 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.
Time frame: On the day of surgery suspected perioperative anaphylaxis
Rate of unplanned ICU admission due to 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.
Time frame: Within 24 hours of suspected perioperative anaphylaxis
Rate of recurrence of perioperative anaphylaxis
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.
Time frame: On the day of surgery in the operating room
Plan to share: Undecided
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