Clinical Trials Logo
  1. Home
  2. Allergy
  3. NCT04046731
  4. Details
NCT04046731 Clinical Trial

Neuromuscular Blocking Agents Utilized During Perioperative Hypersensitivity Evaluation

Allergy Clinical Trial

Official title:
The Negative Predictive Value and Non-irritant Skin Testing Concentrations of Neuromuscular Blocking Agents Utilized During Perioperative Hypersensitivity Evaluation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04046731
Other study ID # 18-007462
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 20, 2019
Est. completion date December 31, 2021

Study information
Verified date February 2022
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The researchers are trying to develop an allergy skin test to help predict allergic responses to medications commonly given to patients during surgery.

Description:

This study will be a prospective study to accurately determine the negative predictive value of skin testing with NMBAs. It is hypothesized that the concentrations that should be used for NMBAs are actually much lower than previously recommended and that the higher incidence of identifiable NMBA induced allergic reactions during anesthesia in the past may be due to irritation of the skin rather than a true allergic reaction (false positives).

Recruitment information / eligibility
Status Completed
Enrollment 187
Est. completion date December 31, 2021
Est. primary completion date December 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All adults > or = to 18 y/o undergoing surgery Exclusion Criteria: - Minors under the age of 18 y/o, Adults unable to consent, or those Adults with previous allergic reaction history during previous surgeries.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Skin Testing
Percutaneous skin prick followed by Intradermal Injections of NMBAs at increasing concentrations compared with an established positive and negative control.

Locations
Country Name City State
United States Mayo Clinic Jacksonville Florida

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Non-Irritant Concentrations to common NMBAs Determine the NIC to common NMBAs 1 Year
Secondary Negative Predictive Value of Intradermal Skin Testing to commonly used NMBAs Determine Negative Predictive Value of Intradermal Skin Testing to commonly used NMBAs 1 Year
Secondary Max Concentration used when skin testing to NMBAs Close gap on the variability of the maximal concentration used when skin testing NMBAs. 1 Year
See also
  Status Clinical Trial Phase
Terminated NCT02032056 - Effect of Probiotics in Reducing Infections and Allergies in Young Children During the Complementary Feeding Period N/A
Completed NCT01842711 - Cumulative Irritation Patch Test N/A
Completed NCT01633840 - New Validated Recipes for Double-blind Placebo-controlled Low Dose Food Challenges N/A
Completed NCT00554983 - Efficacy and Safety From a Recombinant Folding Variant of Bet v 1 Phase 3
Completed NCT00997971 - Growth, Tolerance in Healthy Infants Fed a Partially Hydrolyzed Rice Protein Phase 3
Completed NCT00331929 - Respiratory Health Study of Children in Kiryat Tivon N/A
Completed NCT00232518 - Randomised Controlled Clinical Trials of the Effect of Therapeutic Hookworm Infection in Allergic Rhinoconjunctivitis N/A
Completed NCT00220753 - Air Cleaners for Children and Adolescents With Asthma and Dog Allergy N/A
Completed NCT04126096 - Negative Predictive Value and NIC of Beta-Lactam Antibiotics. N/A
Completed NCT04004351 - Treatment Modalities in Children and Adolescents Suffering From HDM-induced Allergic Rhinitis and/or Asthma
Not yet recruiting NCT05997784 - Study of Indoor Air Pollutants and Their Impact in Childhood Health and Wellbeing
Completed NCT04418999 - Safety and Efficacy of Intracanalicular Dexamethasone Compared to Loteprednol Etabonate in Patients With Keratoconus Early Phase 1
Completed NCT04186949 - Early Origins of Allergy and Asthma
Completed NCT02127801 - Single Ascending-dose Study of the Efficacy, Safety, Tolerability, and Pharmacokinetics of REGN1908-1909 in Allergic, Adult Participants Phase 1
Enrolling by invitation NCT05011071 - The Alberta BLOOM Premature Child Study
Not yet recruiting NCT06330974 - Allergy, Asthma, and Atopic Eczema in Finland
Completed NCT02306473 - The Leaky Lung Test Early Phase 1
Terminated NCT02601690 - Observational Analysis of T Cell Responses to SPIREs for Multiple Allergens in Subjects With Allergy in North America
Completed NCT02596321 - A Study Investigating the Immunologic Effects and Safety of 60-day Treatment of the ALK HDM Tablets in Adult Subjects With HDM-Induced Allergic Rhinitis and/or Atopic Asthma Phase 3
Completed NCT02293343 - 24 Hrs Histamine Profile in Healthy Persons and Patients With Food Intolerance N/A

External Links