Not Yet RecruitingPhase 4ACTRN12610000707066

The effect of sugammadex on the allergic component of rocuronium

The effect of sugammadex on patients being skin tested who are allergic to rocuronium


Sponsor

Sir Charles Gairdner Hospital

Enrollment

10 participants

Start Date

Oct 1, 2010

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

This study investigates whether sugammadex, a drug used to reverse muscle relaxants, can also block the allergic reaction some people have to rocuronium (a common anaesthetic drug). You must be aged 18 to 80 and have a previously confirmed allergy to rocuronium. People who have recently used antihistamines or have skin infections on both arms cannot participate.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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), 0.02

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.


Locations(1)

Australia

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ACTRN12610000707066