None listed
Conditions
Brief summary
Muscle relaxants are the most common cause of allergic reactions in patients having an anaesthetic. One of the most commonly used muscle relaxants is rocuronium. Recently sugammadex has been made available that reverses the effects of rocuronium by encapsulating the drug and preventing it binding at the neuromuscular junction. No one knows the role of sugammadex in someone who has developed an allergic reaction to rocuronium. It is our hypothesis that when sugammadex is combined with rocuronium the allergenic component of rocuronium is covered. If this is true sugammadex may play an important role in the management of patients who have developed an allergic reaction to rocuronium. We will investigate this by skin testing rocuronium alone and the combination of rocuronium and sugammadex in patients who are rocuronium allergic. We will see the effect on skin testing of the combination of the two drugs. Should the combination cause a negative skin test one could conclude that the allergenic component of rocuronium has been covered by the sugammadex.
Interventions
Patients who are allergic to rocuronium (confirmed by skin testing) will be skin tested to the following:
1. Histamine - (positive control) 10mg/ml, skin prick
2. Saline - (negative control), 0.02ml intradermally
3. Rocuronium alone - 0.02ml of 0.01mg/ml intradermally
4. Sugammadex alone - 0.02ml of 0.13mg/ml intradermally (the dose required to reverse 0.01mg/ml rocuronium)
5. Combination of sugammadex and rocuronium - 0.02ml of a mixture of equal volumes of 0.02mg/ml rocuronium and 0.26mg/ml s
Patients who are allergic to rocuronium (confirmed by skin testing) will be skin tested to the following: 1. Histamine - (positive control) 10mg/ml, skin prick 2. Saline - (negative control), 0.02ml intradermally 3. Rocuronium alone - 0.02ml of 0.01mg/ml intradermally 4. Sugammadex alone - 0.02ml of 0.13mg/ml intradermally (the dose required to reverse 0.01mg/ml rocuronium) 5. Combination of sugammadex and rocuronium - 0.02ml of a mixture of equal volumes of 0.02mg/ml rocuronium and 0.26mg/ml sugammadex (final concentrations of each will be 0.01mg/ml and 0.13mg/ml respectively) All five interventions will be given to each participant. They are one off interventions and the results will be read at 20 minutes after the injections. We aim to assess whether sugammadex encapsulates the allergic component of the rocuronium causing a negative skin test in someone who is allergic to rocuronium.
Sponsors
Sir Charles Gairdner Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
Previous allergy to rocuronium confirmed by skin testing
Exclusion criteria
Lack of informed consent Recent anti-histamine use Skin infection of both arms (the site where the skin testing will occur)
Outcome results
None listed