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Trial registered on ANZCTR


Registration number
ACTRN12620000730909
Ethics application status
Approved
Date submitted
23/03/2020
Date registered
13/07/2020
Date last updated
13/07/2020
Date data sharing statement initially provided
13/07/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing blood levels of two preparations of 2% lignocaine for airway anaesthesia.
Scientific title
A comparison of lignocaine plasma levels and efficacy of two preparations of 2% lignocaine for airway topicalisation in healthy physician volunteers
Secondary ID [1] 300845 0
nil known
Universal Trial Number (UTN)
nil
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Airway topicalisation 316754 0
plasma lignocaine levels 316755 0
Condition category
Condition code
Anaesthesiology 314979 314979 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Airway topicalisation with 2% lignocaine for injection, alkalinised with bicarbonate, given by nebuliser and topical spray to nose and mouth, by course participant (anaesthesia or emergency physician) in divided doses according to our protocol up to that needed to achieve successful endoscopy, to a maximum dose of 9mg/kg over 30 minutes (maximum lignocaine dose given pre-calculated for person who is being topicalised taking into account all doses of lignocaine applied the expected period of topicalisation (30 minutes))
Intervention code [1] 317172 0
Treatment: Drugs
Comparator / control treatment
Diluted 2% Topical lignocaine given by nebuliser and topical spray to nose and mouth, by course participant (anaesthesia or emergency physician) in divided doses according to our protocol up to that needed to achieve successful endoscopy, to a maximum dose of 9mg/kg over 30 minutes (maximum lignocaine dose given pre-calculated for person who is being topicalised taking into account all doses of lignocaine applied the expected period of topicalisation (30 minutes))
Control group
Active

Outcomes
Primary outcome [1] 323285 0
To compare the plasma lignocaine level attained by the two preparations (Diluted 2% Topical lignocaine versus Alkalinised 2% intravenous lignocaine) in healthy volunteers, with a standardised method of upper airway topicalisation for endoscopy.
Timepoint [1] 323285 0
at 15, 30, 45 60, 75 and 90 minutes from the end of nebulization
Secondary outcome [1] 381436 0
To compare the difference in mean total dose of lignocaine required by the two preparations in ml and mg (Diluted 2% Topical lignocaine versus Alkalinised 2% intravenous lignocaine) to achieve upper airway endoscopy in healthy volunteers, with a standardised method of upper airway topicalisation. This will be measured by dose required for successful endoscopy to the carina
Timepoint [1] 381436 0
end of topicalisation
Secondary outcome [2] 381437 0
To compare the difference in patient experience (visual analogue scales (VAS) of discomfort) between the two preparations (Diluted 2% Topical lignocaine versus Alkalinised 2% intravenous lignocaine) in healthy volunteers, with a standardised method of upper airway topicalisation for endoscopy.
Timepoint [2] 381437 0
at end of topicalisation

Eligibility
Key inclusion criteria
The study population will be healthy physician volunteers who are prepared to attend the awake fibreoptic intubation course.
Physicians must be on a critical care training programme or have completed such a programme – i.e. likely to be conducting topicalisation and AFOI on patients in the future in order to ensure a baseline of understanding of the procedure and its risks and benefits.
Physicians must be complete or relative novices at topicalisation and AFOI – i.e. completed less than 5 AFOI previously.
Physicians must be healthy - as determined by Gosford Awake Fibreoptic Course medical screening questionnaire.
Physicians must have read and understood the participant information & consent forms and be willing to give written informed consent and
Physicians must be willing to participate to and comply with the study.
Physicians must agree to safety precautions.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Non-physician or non-critical care training/ed.
Unhealthy as determined by Gosford Awake Fibreoptic Course medical screening questionnaire.
Contraindications to endoscopy including epistaxis (nosebleeds), history of significant ear,nose,throat diseases (ENT pathology including laryngospasm), current upper respiratory tract infection (cold), blocked nose for any reason, current respiratory problems (breathing difficulties), previous CVA (stroke).
Affecting lignocaine levels - Cardiac or liver failure (lignocaine metabolism changes), Pregnant or lactating, Obesity (BMI >35), having received lignocaine by any route in prior 24hrs.
Allergy to local anaesthetics (lignocaine)
Failure to obtain intravenous (IV) access
Anaemia or anticoagulated (blood samples).
Medications that could affect lignocaine metabolism (liver affects).

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)
allocation not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
block randomisation produced by software (R statistical software)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint(s)
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis
Descriptive statistics will be used for demographics and to describe plasma lignocaine levels.

Inferential statistics will be used to examine all a priori hypotheses. Where the outcome variable is continuous (e.g total dose of lignocaine required and level of discomfort) a comparison of means by way of an independent t-test is planned. Should the data fail any of the assumptions underlying this test a Mann Whitney U test will be conducted instead to compare medians.

The planned comparisons are; plasma lignocaine level (by repeated measures ANOVA if appropriate), total lignocaine dose (by Friedmans test) and visual analogue score (by Friedmans test).
Relationship between plasma lignocaine level and total dose will be examined with a scatter plot and correlation coefficient. P value 0.05 will be considered significant and 95% confidence interval will be produced for effect sizes.

In the case of missing plasma samples, we have calculated our sample size to allow us to perform a complete-case analysis, which means those participants in whom a lignocaine level is missing will have their data removed from the study.

Recruitment
Recruitment status
Not yet recruiting
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)
NSW
Recruitment hospital [1] 16154 0
Gosford Hospital - Gosford
Recruitment postcode(s) [1] 29688 0
2250 - Gosford

Funding & Sponsors
Funding source category [1] 305300 0
Hospital
Name [1] 305300 0
Gosford Hospital
Address [1] 305300 0
Department of Anaesthesia,
Gosford Hospital
Holden St, Gosford NSW 2250
Country [1] 305300 0
Australia
Primary sponsor type
Hospital
Name
Department of Anaesthesia, Gosford Hospital
Address
Gosford Hospital
Holden St, Gosford NSW 2250
Country
Australia
Secondary sponsor category [1] 305663 0
None
Name [1] 305663 0
Address [1] 305663 0
Country [1] 305663 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305639 0
South Eastern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 305639 0
Prince of Wales Hospital
G71 East Wing , Edmund Blacket Building
Randwick
NSW 2031
Ethics committee country [1] 305639 0
Australia
Date submitted for ethics approval [1] 305639 0
13/08/2019
Approval date [1] 305639 0
22/01/2020
Ethics approval number [1] 305639 0
2019/ETH12718

Summary
Brief summary
This double-blinded, randomised controlled clinical trial of healthy physician volunteers is designed to determine if a difference exists in the median and range of plasma lignocaine concentrations (mcg/ml) in healthy volunteers for two preparations of lignocaine [topical 4% lignocaine diluted to 2% (as currently used by the Gosford awake fibreoptic intubation course) and alkalinised 2% intravenous lignocaine (1ml 8.4% sodium bicarbonate per 10ml 2% IV lignocaine)] when used for topicalisation of the airway for endoscopy. We will also look at comfort scores of participants.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101050 0
Dr Clare Hayes Bradley
Address 101050 0
c/o Aeromedical Operations, NSW Ambulance
33 Nancy Ellis Leebold Drive
Bankstown Airport
NSW 2200
Country 101050 0
Australia
Phone 101050 0
+612 9320 7777
Fax 101050 0
Email 101050 0
clare.hayesbradley@health.nsw.gov.au
Contact person for public queries
Name 101051 0
Dr Clare Hayes Bradley
Address 101051 0
c/o Aeromedical Operations, NSW Ambulance
33 Nancy Ellis Leebold Drive
Bankstown Airport
NSW 2200
Country 101051 0
Australia
Phone 101051 0
+612 9320 7777
Fax 101051 0
Email 101051 0
clare.hayesbradley@health.nsw.gov.au
Contact person for scientific queries
Name 101052 0
Dr Matthew Miller
Address 101052 0
c/o Aeromedical Operations, NSW Ambulance
33 Nancy Ellis Leebold Drive
Bankstown Airport
NSW 2200
Country 101052 0
Australia
Phone 101052 0
+612 9320 7777
Fax 101052 0
Email 101052 0
matthew.miller1@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
not included in approved participant consent forms
What supporting documents are/will be available?
No other documents available
Summary results
No Results