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Perioperative Anaphylaxis in an Egyptian Population.

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03393091
Recruitment Status : Unknown
Verified April 2018 by Hytham Hussien Kamel Mohamed Shoeib, Assiut University.
Recruitment status was:  Recruiting
First Posted : January 8, 2018
Last Update Posted : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
Hytham Hussien Kamel Mohamed Shoeib, Assiut University

Brief Summary:

Perioperative anaphylaxis is associated with significant morbidity and mortality. Most textbooks describe it as a rare event of the order of 1 in 10 to 1 in 20,000 general anaesthetic cases. However, a recent study in the United Kingdom suggested that 1 in 350 cases have features suspicious of perioperative anaphylaxis. This study suggests that perioperative anaphylaxis may be under recognised and under reported.

When perioperative anaphylaxis is recognised, it would be ideal to carry out investigations firstly to confirm the diagnosis of anaphylaxis and secondly to identify the causative agent. The latter can be difficult in the context of anaesthesia where the patient is exposed to several drugs and other reagents in a short space of time.

One of the interesting aspects of perioperative anaphylaxis is that there is variability in its epidemiology between different countries, for example between the United Kingdom, France, Scandinavia and Australia and New Zealand. There are currently no data from Egypt to include in such comparisons and to inform clinical practice.

As well as being at risk if a drug allergen is not identified, patients can also be at risk from an incorrect allergy label. The most common example of this is penicillin allergy where fewer than 10% of patients with a history of penicillin allergy are found to be allergic. Incorrect penicillin allergy labels are potentially harmful for patients attending for surgery because the label independently increases the risk of developing infection to resistant organisms, longer hospital stays and mortality.


Condition or disease
Perioperative/Postoperative Complications Drug-Induced Anaphylaxis

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Perioperative Anaphylaxis in Egypt (In Assiut University Hospitals).
Actual Study Start Date : January 15, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anaphylaxis

Group/Cohort
Incidence of possible anaphylaxis
Data will be collected on 1000 consecutive general anaesthetic procedures in Assiut University Hospitals. After each elective operating list the anaesthetist will be asked to complete a form in which they will document the number of patients receiving general anaesthesia on the list and the number of those patients who developed any of the following features: unexpected, unexplained hypotension; unexpected bronchospasm resistant to treatment; angioedema; urticaria; severe itching; widespread erythema



Primary Outcome Measures :
  1. Incidence of suspected perioperative anaphylaxis in an Egyptian population. [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
  • Data will be collected on 1000 consecutive general anaesthetic procedures in Assiut University Hospitals.
  • A blood cell sample for mast cell tryptase will be taken immediately prior to surgery and 1 hour following induction of anaesthesia in the previously mentioned groups of patients (n = 30).
  • Skin prick and intradermal testing. The study will be done on 2 groups. The first will be patients who have not received any NMDBs during their lifetime and the second will be patients who have received an NMDB without complication.
  • Patients suitable for this study will be those who are deemed to be low risk for true penicillin allergy. The criteria as follows:

    1. History of allergic reaction occurring more than 15 years ago
    2. Symptoms are either unknown, a non-specific rash (erythema and a non-raised rash that was not itchy), nausea or diarrhoea.
    3. No symptoms suggestive of a true allergic reaction (swelling, urticaria, rash, itching, anaphylaxis)
Criteria

Inclusion Criteria:

  • In order to define the incidence of possible anaphylaxis, data will be collected on 1000 consecutive general anaesthetic procedures in Assiut University Hospitals.
  • A blood cell sample for mast cell tryptase will be taken immediately prior to surgery and 1 hour following induction of anaesthesia in the following groups of patients (n = 30 in each case):

    1. Children undergoing elective surgery between the ages of 3 and 10 years
    2. Adults between the ages of 16 and 30 years undergoing orthopaedic trauma surgery
    3. Adults more than 60 years of age undergoing orthopaedic surgery
    4. Women of any age undergoing gynaecological surgery
    5. Adults of any age undergoing emergency general surgery

    (g) Women undergoing caesarean section under general or regional anaesthesia

  • Skin prick and intradermal testing will be done using available neuromuscular blocking drugs. The study will be done on 2 groups of individuals with no history of anaesthetic problems. The first group will be patients, who as far as can be determined, have not received any NMDBs during their lifetime and the second group will be patients who it is known have received an NMDB without complication.
  • Patients presenting at Assiut University Hospital for elective surgery with a self-reported penicillin allergy will be questioned. Patients suitable for this study will be those who are deemed to be low risk for true penicillin allergy. The criteria for identifying a patient at low risk are as follows:

    1. History of allergic reaction occurring more than 15 years ago
    2. Symptoms are either unknown, a non-specific rash (erythema and a non-raised rash that was not itchy), nausea or diarrhoea.
    3. No symptoms suggestive of a true allergic reaction (swelling, urticaria, rash, itching, anaphylaxis)

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): NCT03393091


Contacts
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Contact: Hytham Shoeib 00201003544155 hythamonline@gmail.com

Locations
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Egypt
Assiut university hospitals Recruiting
Assiut, Egypt
Contact: Hytham Shoeib         
Sponsors and Collaborators
Assiut University
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Responsible Party: Hytham Hussien Kamel Mohamed Shoeib, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03393091    
Other Study ID Numbers: AssiutU222
First Posted: January 8, 2018    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Anaphylaxis
Postoperative Complications
Shock
Pathologic Processes
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases