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Trial registered on ANZCTR


Registration number
ACTRN12611000914965
Ethics application status
Approved
Date submitted
24/08/2011
Date registered
25/08/2011
Date last updated
4/04/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of routine reversal of neuromuscular blockade on surgical conditions for thyroid surgery
Scientific title
The effect of routine reversal using neostigmine, of neuromuscular blockade, on neuromuscular monitoring of the laryngeal nerve during thyroid surgery- a double blinded randomised control trial
Secondary ID [1] 262913 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Reversal of neuromuscular blockade during thyroid surgery 270641 0
Condition category
Condition code
Anaesthesiology 270813 270813 0 0
Anaesthetics
Surgery 270815 270815 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Atracurium 0.4mg/kg given as an intubating dose, given intravenously as a bolus, then reversal at 30 mins with neostigmine 2.5mg and glycopyrrolate 0.4mg, intravenously as a bolus, if in the study arm
Intervention code [1] 269266 0
Treatment: Drugs
Comparator / control treatment
Normal saline injection at 30 mins, following the intubating dose of atracurium 0.4mg/kg
Control group
Placebo

Outcomes
Primary outcome [1] 279508 0
Surgical operating conditions for NIM monitor, as subjectively described by surgeon as adequate, or inadequate
Timepoint [1] 279508 0
30 mins after induction the study or placebo drugs will be given, the time point of NIM stimulation is when the surgeon is ready- usually 45-60 mins
Secondary outcome [1] 287766 0
Time to stimulation using NIM moniter
Timepoint [1] 287766 0
At the time of stimulation with NIM moniter
Secondary outcome [2] 287767 0
Trial of four nerve stimulation, using a peripheral nerve stimulator attached to the hand of each participant
Timepoint [2] 287767 0
Five mins after relaxant given
Secondary outcome [3] 287768 0
Trial of four nerve stimulation
Timepoint [3] 287768 0
60 mins

Eligibility
Key inclusion criteria
Thyroid surgery at Peninsula Health
Minimum age
18 Years
Maximum age
100 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Allergy to atracurium
Musculoskeletal abnormality
Surgeon not using NIM stimulation intraoperatively
Recurrent laryngeal nerve injury/abnormality

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will be recruited from the thyroid surgery waiting list at Peninsula Health, and will be screened through the pre admission clinic for suitability. Once enrolled and consented, computer generation of randomisation will occur, an independent person will prepare the study or placebo injection following instructions in a concealed envelope and will hand the syringe to the anaesthetist for injection
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generation, will allocate individuals, then an independent person will take the allocated allotted envelope and hand this to another independent person for preparation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269730 0
Hospital
Name [1] 269730 0
Frankston Hospital
Address [1] 269730 0
Hastings Road
Frankston
Victoria
3199
Country [1] 269730 0
Australia
Primary sponsor type
Individual
Name
Emma Boden
Address
Frankston Hospital
Hastings Road
Frankston
Victoria
3199
Country
Australia
Secondary sponsor category [1] 268772 0
Individual
Name [1] 268772 0
Stuart Marshall
Address [1] 268772 0
Frankston Hosptial
Hastings Road
Frankston
Vicotoria
3199
Country [1] 268772 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271698 0
Peninsula Health
Ethics committee address [1] 271698 0
Frankston Hosptial
Hastings Road
Frankston
Victoria
3199
Ethics committee country [1] 271698 0
New Zealand
Date submitted for ethics approval [1] 271698 0
18/07/2011
Approval date [1] 271698 0
Ethics approval number [1] 271698 0
HREC/11/PH/62

Summary
Brief summary
Participants will receive a standard anaesthetic with- propofol induction, remifentanil induction, 2x ED 95 (intubating conditions) atracurium 0.4mg/km, sevoflurane, dexamethasone and cefazolin.
At 30 mins post induction patients will either get neostigmine/glycopyrrolate injection or saline injection prepared by an independent person, given by anaesthetist.

Then the surgeon will determine, using the NIM stimulator whether the reversal of neuromuscular blockade is adequate.
Trial website
Nil
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33071 0
Dr Stuart Marshall
Address 33071 0
Frankston Hospital
Hastings Road
Frankston
Victoria 3199
Country 33071 0
Australia
Phone 33071 0
+61397881473
Fax 33071 0
Email 33071 0
smarshall@phcn.vic.gov.au
Contact person for public queries
Name 16318 0
Mr The Convener, Peninsula Health Human Research and Ethics Comittee
Address 16318 0
Frankston Hospital
Hastings Road
Frankston
Victoria
3199
Country 16318 0
Australia
Phone 16318 0
+61 397881473
Fax 16318 0
Email 16318 0
researchethics@phcn.vic.gov.au
Contact person for scientific queries
Name 7246 0
Dr Emma Boden
Address 7246 0
Frankston Hospital
Hastings Road
Frankston
Victoria
3199
Country 7246 0
Australia
Phone 7246 0
+61 397847445
Fax 7246 0
Email 7246 0
eboden@phcn.vic.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary