Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000072213
Ethics application status
Approved
Date submitted
10/12/2008
Date registered
28/01/2009
Date last updated
28/01/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of 0.5mg/kg and 1.0mg/kg Suxamethonium in patients undergoing Electroconvulsive Therapy (ECT)
Scientific title
Comparison of 0.5mg/kg and 1mg/kg Suxamethonium in patients undergoing voluntary ECT(Electroconvulsive Therapy)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
the incidence and severity of postprocedure myalgia after ECT comparing two different doses of muscle relaxant 4114 0
patient undergoing voluntary ECT. 4115 0
compare the amount of post therapy myalgia between the two dosage groups 4116 0
Condition category
Condition code
Anaesthesiology 4309 4309 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
comparison two doses of suxamethonium in ECT. suxamethonium is a muscle relaxant administered intravenously at the time of ECT to reduce muscle spasms. It will be administered in this way on two consecutive occasions within a week of each other at the time of ECT. On one occassion, the dosage amount of Suxamethonium administered to participants will be 1.0mg/kg
Intervention code [1] 3825 0
Treatment: Drugs
Comparator / control treatment
0.5mg/kg suxamethonium, will be adminsitered intravenously at the time of ECT to act as a muscle relaxant to reduce the amount of muscle spasms. Each dosage amount, 1.0mg/kg and 0.5mg/kg, of Suxamethonium will be administered on only one occassion each
Control group
Active

Outcomes
Primary outcome [1] 5199 0
post procedure myalgia will be assessed by postprocedure questionaire completed by the patient at one hour post procedure
Timepoint [1] 5199 0
at one hour from procedure and at 24hrs via a phone call for the 24hr assessment
Primary outcome [2] 5200 0
degree of fit modification: this is assessed by an observor who will classify how well the fit was modified. A well modified fit with minimal observed spasm is desirable and a less well modified fit with more muscle spasm is undesirable
Timepoint [2] 5200 0
this assessment will take place at the time of the fit and the classification will take place immediately.
Primary outcome [3] 5344 0
the status of myalgia in patients after the procedure. This will be achieved by asking the patient to nominate the degree of myalgia on a four point scale.
Timepoint [3] 5344 0
one hour post procedure and at 24hr post procedure.
Primary outcome [4] 5345 0
the status of myalgia in patients after the procedure. This will be achieved by asking the patient to nominate the degree of myalgia on a four point scale.
Timepoint [4] 5345 0
one hour post procedure and at 24hr post procedure.
Secondary outcome [1] 8753 0
quality of electroencephalogram (EEG) recording. The fit is monitored on the EEG, brain activity, and this is used to assess the adequacy of the fit. A poorly modified fit with significant muscle activity should result in artefact and poor quality recording whereas a well modified fit should result in a higher quality recording with less interference. This will be assessed off line by a blinded psychiatrist who will grade th equality of the recording on a four point scale. recordings will be presented to the assessor in a randomised fashion.
Timepoint [1] 8753 0
this will occur at the completion of the study period and will be blinded.

Eligibility
Key inclusion criteria
voluntary patients already booked independently for ECT
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
involuntary patient or patients deemed
unable to give consent

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
informed consent obtained and patient allocated randomly to receive either dose of suxamethonium then at next treatment with no other alterations they will have the other study dose that they did not receive on the previous ECT. The person enrolling the patient is unaware of which group they will be allocated to. Allocation is by way of 50 sequential numbers with random generation from a computer. . Thereafter this information is contained in sequentially numbered envelopes and the drug will be made up and given to the treating anaesthetist to administer by a second anaesthetist who is not involved in treating the patient
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
list of 50 numbers sequenced randomly by computer. Patients will be allocated to groups based on this
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4275 0
Self funded/Unfunded
Name [1] 4275 0
Country [1] 4275 0
Australia
Primary sponsor type
Hospital
Name
Peninsula Health
Address
Hastings Rd. Frankston, Victoria 3199
Country
Australia
Secondary sponsor category [1] 3848 0
None
Name [1] 3848 0
Address [1] 3848 0
Country [1] 3848 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6329 0
Human Research and Ethics Committee Peninsula Health
Ethics committee address [1] 6329 0
Ethics committee country [1] 6329 0
Australia
Date submitted for ethics approval [1] 6329 0
Approval date [1] 6329 0
03/12/2008
Ethics approval number [1] 6329 0
2008-50

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35030 0
Address 35030 0
Country 35030 0
Phone 35030 0
Fax 35030 0
Email 35030 0
Contact person for public queries
Name 12377 0
A/Prof T Loughnan
Address 12377 0
Department of Anaesthesia
Frankston Hospital
Hastings Rd
Frankston, Victoria 3199
Country 12377 0
Australia
Phone 12377 0
+61 3 97847445
Fax 12377 0
+613 97847441
Email 12377 0
[email protected]
Contact person for scientific queries
Name 3305 0
A/Prof T Loughnan
Address 3305 0
Department of Anaesthesia
Frankston Hospital
Hastings Rd
Frankston, Victoria 3199
Country 3305 0
Australia
Phone 3305 0
+613 97847445
Fax 3305 0
+613 97847441
Email 3305 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.