Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000707066
Ethics application status
Not yet submitted
Date submitted
23/08/2010
Date registered
25/08/2010
Date last updated
25/08/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of sugammadex on the allergic component of rocuronium
Scientific title
The effect of sugammadex on patients being skin tested who are allergic to rocuronium
Secondary ID [1] 252542 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rocuronium allergy 258023 0
Condition category
Condition code
Inflammatory and Immune System 258190 258190 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 257065 0
Treatment: Drugs
Intervention code [2] 257066 0
Treatment: Other
Comparator / control treatment
All participants will receive the same five interventions
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259047 0
Whether or not a negative skin test results when sugammadex is combined with rocuronium in patients who are allergic to rocuronium
Timepoint [1] 259047 0
Skin test is read 20 minutes after drugs injected
Secondary outcome [1] 265310 0
nil
Timepoint [1] 265310 0
nil

Eligibility
Key inclusion criteria
Previous allergy to rocuronium confirmed by skin testing
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Lack of informed consent
Recent anti-histamine use
Skin infection of both arms (the site where the skin testing will occur)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients who have previously skin tested positive to rocuronium will be contacted by phone and voluntary, informed consent obtained. All patients will receive the same testing ie no randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257509 0
Hospital
Name [1] 257509 0
Sir Charles Gairdner Hospital
Country [1] 257509 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Ave
Nedlands 6009
Western Australia
Country
Australia
Secondary sponsor category [1] 256745 0
None
Name [1] 256745 0
Address [1] 256745 0
Country [1] 256745 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 259537 0
Ethics committee address [1] 259537 0
Ethics committee country [1] 259537 0
Date submitted for ethics approval [1] 259537 0
31/08/2010
Approval date [1] 259537 0
Ethics approval number [1] 259537 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31555 0
Address 31555 0
Country 31555 0
Phone 31555 0
Fax 31555 0
Email 31555 0
Contact person for public queries
Name 14802 0
Dr Russell Clarke
Address 14802 0
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands WA 6009
Country 14802 0
Australia
Phone 14802 0
+61 412 288 818
Fax 14802 0
Email 14802 0
[email protected]
Contact person for scientific queries
Name 5730 0
Dr Russell Clarke
Address 5730 0
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands WA 6009
Country 5730 0
Australia
Phone 5730 0
+61 412 288 818
Fax 5730 0
Email 5730 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.