Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000459022
Ethics application status
Approved
Date submitted
29/05/2010
Date registered
4/06/2010
Date last updated
12/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
How does local anesthetic airway topicalisation, for awake fiberbreoptic intubation (AFOI), affect patient reaction time?
Scientific title
The Psychometric effect of topical lignocaine on healthy volunteers in an awake fibre optic course, tested by complex reaction time and balance and related to plasma lignocaine levels.
Secondary ID [1] 251900 0
nil
Universal Trial Number (UTN)
U1111-1115-3912
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
psychometric effect of lignocaine 257491 0
Condition category
Condition code
Anaesthesiology 257642 257642 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Lignocaine topicalization for awke fibre optic intubation.
a)"Spray as you Go" topicalization with Micro Atomizer Device (MAD)
b)Dose titrated to comfort with instumentation.
(Difference in dose noted and related to Psychometric effects and plasma levels.)
c)Max dose less than 9mg/kg as per safety guidelines
d)Duration from start of topicalization to intubation 30 minutes on average.
Intervention code [1] 256585 0
Treatment: Drugs
Comparator / control treatment
Each participant is their own controll with complex reaction time test and balance test pre and post exposure to lignocaine.
Control group
Active

Outcomes
Primary outcome [1] 258549 0
Psychometric test pre and post exposure.
(Composite Primary Outcome)

(1)Complex Reaction time test: Reaction time measured to the identification of a simple object.
Example: Picture of a dog with the word "DOG" next to it. True/False option with the reaction time to answer masured.

(2)Balance test scored to 10
stand with feet together =2
arms at 90 deg from side =2
bend one knee to 90 deg = 2
look up =2
close eyes =2

Loss of 1 point for loss of balance with correction
Loss of 2 points with loss of ballance without correction
Timepoint [1] 258549 0
*pre exposure for baseline
*post exposure immediately and at 60min (correlates with maximum plasma level)
Secondary outcome [1] 264394 0
relation of plasme lignocaine concentration to psychometric outcomes
Timepoint [1] 264394 0
pre exposure and at 60 min

Eligibility
Key inclusion criteria
voluntary participants in an awake fibre optic course
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Known intolerance or allergy to any study drug. (Lidocaine)
2. Active psychosis or history of schizophrenia
3. Pregnancy
4. Severe heart disease, liver disease, diabetes or asthma.
5. Epilepsy
6. History of epistaxis or nasal problems

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Healthy volunteers on an airway teaching course that would have exposure to topicalized lignocaine without the study being conducted.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/06/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257079 0
Hospital
Name [1] 257079 0
Fremantle Hospital
Country [1] 257079 0
Australia
Primary sponsor type
Hospital
Name
Fremantle Hospital
Address
Alma St
Fremantle
WA 6969
Country
Australia
Secondary sponsor category [1] 256338 0
None
Name [1] 256338 0
Address [1] 256338 0
Country [1] 256338 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259102 0
HUMAN RESEARCH ETHICS COMMITTEE /SOUTH METROPOLITAN AREA HEALTH SERVICE
Ethics committee address [1] 259102 0
Level 3 Colonial House,
Royal Perth Hospital,
GPO Box X2213,
Perth
WA 6847
Ethics committee country [1] 259102 0
Australia
Date submitted for ethics approval [1] 259102 0
08/06/2010
Approval date [1] 259102 0
Ethics approval number [1] 259102 0

Summary
Brief summary
Awake fibreoptic intubation (AFOI) is the method of choice for intubation and securing of a potentially difficult airway. Routine practice worldwide involves ‘topicalisation’ (numbing) of the airway with Local Anaesthetic (LA) to enable a fiber optic camera to be advanced through the airway and into the trachea, usually with the patient awake and under no sedative influence.

Currently there are no data on the effects of the LA used this way on cognitive or motor function, and patients are allowed to return home shortly after such a procedure. There is no advice given with regards to driving or operating heavy machinery despite anesthetists who have had this procedure describing ‘funny feelings’ following administration of topical LA and multiple studies that report subjective feeelings of dizzines, tingling, euphoria and dysphoria

We wish to assess the impact of LA on reaction time (and hence both neural and motor function) following volunteer participation in an AFOI Course that we run half yearly for anesthetists
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31241 0
Address 31241 0
Country 31241 0
Phone 31241 0
Fax 31241 0
Email 31241 0
Contact person for public queries
Name 14488 0
Dr. J.M.D. van Riet
Address 14488 0
C/o Anaesthetic Department
Fremantle Hospital
Alma St
Fremantle WA 6969
Country 14488 0
Australia
Phone 14488 0
0061 08 9431 3333
Fax 14488 0
Email 14488 0
[email protected]
Contact person for scientific queries
Name 5416 0
Dr. J.M.D. van Riet
Address 5416 0
C/o Anaesthetic Department
Fremantle Hospital
Alma St
Fremantle WA 6969
Country 5416 0
Australia
Phone 5416 0
0061 08 9431 3333
Fax 5416 0
Email 5416 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.