Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000664145
Ethics application status
Approved
Date submitted
10/12/2015
Date registered
3/05/2019
Date last updated
3/05/2019
Date data sharing statement initially provided
3/05/2019
Date results information initially provided
3/05/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Quantifying the effect and variability of neuromuscular blocking drugs on patients undergoing surgery.
Scientific title
Quantifying the effect and the intra- and inter-patient variability of neuromuscular blocking (NMB) drugs on patients undergoing surgery that requires two or more doses of NMB.
Secondary ID [1] 288123 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anaesthesia 296999 0
surgery. 297000 0
Condition category
Condition code
Anaesthesiology 297251 297251 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Non-interventional. Administration of NMB drugs during surgery under general anaesthesia, in cases where more than one dose of NMB is administered.
The PQRS - an international quality of recovery questionnaire - will be used pre-surgery, and twice post-surgery - after emergence from anaesthesia and at Day 1 post surgery.
Intervention code [1] 293432 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296836 0
Quantifying patient requirement for NMB during anaesthesia, using Train of Four (TOF) monitoring.
Timepoint [1] 296836 0
Point of administration of NMB.
Primary outcome [2] 296878 0
Patient quality of recovery in Post Anaesthetic Care Unit (PACU), as determined by the PQRS (Post-Operative Quality of Recovery Scale) that evaluates physiological, nociceptive, functional, cognitive and emotional recovery domains, as well as overall patient perspective.
Timepoint [2] 296878 0
Within 30 minutes of last stitch (i.e.last surgical stitch).
Primary outcome [3] 296879 0
Patient quality of recovery in Post Anaesthetic Care Unit (PACU), as determined by the PQRS (Post-Operative Quality of Recovery Scale) that evaluates physiological, nociceptive, functional, cognitive and emotional recovery domains, as well as overall patient perspective.
Timepoint [3] 296879 0
Day 1 post-surgery.
Secondary outcome [1] 319487 0
Calculated NMB drug level at the time the second twitch (T2) of a train-of-four (TOF) returns, assessed by Aisys Anaesthetic Machine..
Timepoint [1] 319487 0
Return of T2.
Secondary outcome [2] 319584 0
Time from first dose of NMB to disappearance of T1 as assessed by Aisys Anaesthetic Machine. (TOF ratio is used in monitoring recovery from neuromuscular block.. T1 is the first indicator of early return of neuromuscular function.)
Timepoint [2] 319584 0
Disappearance of T1.
Secondary outcome [3] 319585 0
Combined (composite)Train of Four (TOF) and drug level at the time any NMB antagonist is administered, as shown by Aisys Anaesthetic Machine.
Timepoint [3] 319585 0
At administration of NMB antagonist.
Secondary outcome [4] 319586 0
Combined TOF ratio and NMB drug level at the time of last NMT measurement, as assessed by the Aisys Anaesthetic Machine.(Composite outcome.)
Timepoint [4] 319586 0
Time of last NMT measurement.
Secondary outcome [5] 319587 0
Peak drug level at disappearance of T1, as assessed by the Aisys Anaesthetic Machine.
Timepoint [5] 319587 0
Disappearance of T1.

Eligibility
Key inclusion criteria
Patients having surgeries lasting more than 60 minutes, who require more than one dose of rocuronium muscle relaxant.
Minimum age
16 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients having surgery that will last for less than 60 minutes.
Patients having surgery that will require fewer than 2 doses of neuromuscular blockade NMB).

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Required data will be collected from the Aisys Anaesthetic Machine and from a trained observer. Drug dosage received will be noted as will the degree of NMB. At the time of the second twitch (T2) of a train-of-four (TOF), calculated drug levels will be recorded. Time from the first dose of NMB to disappearance of T1 will be documented, along with peak drug level at this point. The TOF ratio and drug level when a NMB antagonist is given, and at time of last degree of blockade measurement will be recorded. The PQRS tool will be used pre-surgery, and twice post-surgery - after emergence from anaesthesia and at Day 1 post surgery. This is a studentship study consenting an opportunistic sample of patients & where surgery is expected to last >60min & in whom >1 dose of NMB is expected. Patient numbers pragmatically calculated as =/>60 based on previous experience with studentship numbers, and which we anticipate will provide sufficient data to meet our study aims .

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
9/11/2015
Date of last participant enrolment
Anticipated
Actual
20/01/2016
Date of last data collection
Anticipated
Actual
26/01/2016
Sample size
Target
60
Accrual to date
Final
63
Recruitment outside Australia
Country [1] 7405 0
New Zealand
State/province [1] 7405 0
Canterbury

Funding & Sponsors
Funding source category [1] 292535 0
Commercial sector/Industry
Name [1] 292535 0
Anaesthetists' Instrument Pool
Country [1] 292535 0
New Zealand
Primary sponsor type
Hospital
Name
Christchurch Hospital
Address
Christchurch Hospital
2 Riccarton Ave
PB 4710
Christchurch 8410
Country
New Zealand
Secondary sponsor category [1] 291249 0
None
Name [1] 291249 0
Address [1] 291249 0
Country [1] 291249 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294008 0
New Zealand Health and Disability Ethics Committee
Ethics committee address [1] 294008 0
POBox 5013
Wellington 6154
Wellington
Ethics committee country [1] 294008 0
New Zealand
Date submitted for ethics approval [1] 294008 0
07/07/2015
Approval date [1] 294008 0
14/07/2015
Ethics approval number [1] 294008 0
NZ/1/986808

Summary
Brief summary
Neuromuscular blocking drugs (NMB) are commonly used during anaesthesia to provide muscle relaxation to facilitate surgery. Although various agents can be used to antagonise the residual effect of these drugs at the end of surgery there is clear evidence that a proportion of patients have residual effects of these drugs in the recovery (PACU) area and that this may be associated with increased morbidity in the post-operative period. These residual effects can be minimised by careful use and monitoring of these drugs and effects.
New monitoring modalities (NMT monitors) allow us to more accurately measure the degree of paralysis produced by these drugs. We also have tools that calculate the levels of NMB drugs in the body. We have empirically observed that there is a large inter-patient variability in the drug levels associated with a given degree of blockade, but an individual patient will have a similar response at a similar drug level after repeated doses of NMBs.
While NMBs are used in less than 50% of anaesthetics, with changes in surgical practice there is an increasing requirement for “deeper” block at the same time as the dangers of residual effects are being increasingly recognised. Newer tools allow us to better titrate and manage these drugs. The primary purpose of this study is to quantify variability in patient response, using routine clinical tools, to give us an understanding of how we can use these tools to improve care. Specific follow-up will allow us to relate quality of recovery to usage of NMB drugs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62134 0
A/Prof Dr R R Kennedy
Address 62134 0
Department of Anaesthesia
Christchurch Hospital
PB 4710
Christchurch 8410
Country 62134 0
New Zealand
Phone 62134 0
+6433640288
Fax 62134 0
+6433640289
Email 62134 0
[email protected]
Contact person for public queries
Name 62135 0
Mrs Margie McKellow
Address 62135 0
Department of Anaesthesia
Christchurch Hospital
PB 4710
Christchurch 8410
Country 62135 0
New Zealand
Phone 62135 0
+6433640288
Fax 62135 0
+6433640289
Email 62135 0
[email protected]
Contact person for scientific queries
Name 62136 0
A/Prof Dr RR Kennedy
Address 62136 0
Department of Anaesthesia
Christchurch Hospital
PB 4710
Christchurch 8410
Country 62136 0
New Zealand
Phone 62136 0
+6433640288
Fax 62136 0
+6433640289
Email 62136 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Analysed study data will be available. IPD will not be available for general access except by approval of CI, since patients were not informed of this during consent process.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.