The Clinical Study on Pseudo-allergic Reaction to Anesthetic Drugs During General Anesthesia

NCT03157180 | Unknown

• 1 other identifier: 201703781
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Perioperative anaphylactic reactions are immediate, hypersensitive reactions that are potentially life-threatening resulting from a sudden release of mediators from mast cells and basophiles. Which is due to either immune (IgE or non-IgE mediated) or non-immune mechanisms. Pseudo-allergic are defined as those reactions that produce the same clinical symptoms with anaphylaxis but are not IgE mediated, occur through a direct nonimmune-mediated release of mediators from mast cells and/or basophils or result from direct activation.so pseudo-allergic reactions do not require previous contact with the substance. Recent studies have shown that a mast-cell-specific receptor,G-protein-coupled receptor MRGPRX2,is crucial for pseudo-allergic drug reactions.in this study. In the study, we will examine the MRGPRX2 gene in patients with pseudo-allergic reactions during anesthesia, aiming at clarifying the relationship between pseudo-allergic reactions and MRGPRX2 gene.

Conditions

General Anesthetic Drug Allergy

Outcome Measures

Primary Outcomes (1)

• Gene sequence

  Biobanking of blood from patients with allergic reactions or no allergic reactions (control group) in general anesthesia at xiangya hospital

  6 weeks

Study Arms (2)

Test group

general anesthesia There is allergic reaction during anesthesia Sign informed consent

Control group

general anesthesia There is no allergic reaction during anesthesia Sign informed consent

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all patients under general anesthesia in Xiangya hospital

You may qualify if:

• general anesthesia There is allergic reaction during anesthesia Sign informed consent

You may not qualify if:

• general anesthesia There is no allergic reaction during anesthesia Sign informed consent

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

Central South University Xiangya Hospital

Changsha, Hunan, 410013, China

RECRUITING

Related Publications (8)

• Michavila Gomez AV, Belver Gonzalez MT, Alvarez NC, Giner Munoz MT, Hernando Sastre V, Porto Arceo JA, Indurain BV; Drug allergy Work Group of the Spanish Society of Paediatric Allergy, Immunology (SEICAP). Perioperative anaphylactic reactions: Review and procedure protocol in paediatrics. Allergol Immunopathol (Madr). 2015 Mar-Apr;43(2):203-14. doi: 10.1016/j.aller.2013.07.012. Epub 2013 Nov 11.

  PMID: 24231150 BACKGROUND

• Ewan PW, Dugue P, Mirakian R, Dixon TA, Harper JN, Nasser SM; BSACI. BSACI guidelines for the investigation of suspected anaphylaxis during general anaesthesia. Clin Exp Allergy. 2010 Jan;40(1):15-31. doi: 10.1111/j.1365-2222.2009.03404.x.

  PMID: 20205694 BACKGROUND

• Mertes PM, Malinovsky JM, Jouffroy L; Working Group of the SFAR and SFA; Aberer W, Terreehorst I, Brockow K, Demoly P; ENDA; EAACI Interest Group on Drug Allergy. Reducing the risk of anaphylaxis during anesthesia: 2011 updated guidelines for clinical practice. J Investig Allergol Clin Immunol. 2011;21(6):442-53.

  PMID: 21995177 BACKGROUND

• Mertes PM, Laxenaire MC, Alla F; Groupe d'Etudes des Reactions Anaphylactoides Peranesthesiques. Anaphylactic and anaphylactoid reactions occurring during anesthesia in France in 1999-2000. Anesthesiology. 2003 Sep;99(3):536-45. doi: 10.1097/00000542-200309000-00007.

  PMID: 12960536 BACKGROUND

• Reitter M, Petitpain N, Latarche C, Cottin J, Massy N, Demoly P, Gillet P, Mertes PM; French Network of Regional Pharmacovigilance Centres. Fatal anaphylaxis with neuromuscular blocking agents: a risk factor and management analysis. Allergy. 2014 Jul;69(7):954-9. doi: 10.1111/all.12426. Epub 2014 May 10.

  PMID: 24813248 BACKGROUND

• McNeil BD, Pundir P, Meeker S, Han L, Undem BJ, Kulka M, Dong X. Identification of a mast-cell-specific receptor crucial for pseudo-allergic drug reactions. Nature. 2015 Mar 12;519(7542):237-41. doi: 10.1038/nature14022. Epub 2014 Dec 17.

  PMID: 25517090 BACKGROUND

• Ebo DG, Fisher MM, Hagendorens MM, Bridts CH, Stevens WJ. Anaphylaxis during anaesthesia: diagnostic approach. Allergy. 2007 May;62(5):471-87. doi: 10.1111/j.1398-9995.2007.01347.x.

  PMID: 17441788 BACKGROUND

• Dewachter P, Mouton-Faivre C, Emala CW. Anaphylaxis and anesthesia: controversies and new insights. Anesthesiology. 2009 Nov;111(5):1141-50. doi: 10.1097/ALN.0b013e3181bbd443. No abstract available.

  PMID: 19858877 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood specimen

Study Officials

• Wangyuan Zou

  Central South University

  STUDY DIRECTOR

Central Study Contacts

Wangyuan Zou, MD,Ph.D.

CONTACT

18073137075; wangyuanzou@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 17, 2017
• Study Start: April 1, 2017
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: May 17, 2017

Record last verified: 2017-05

Locations

CN (1)