Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000251022
Ethics application status
Approved
Date submitted
12/03/2010
Date registered
24/03/2010
Date last updated
12/04/2019
Date data sharing statement initially provided
12/04/2019
Date results information initially provided
12/04/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Incidence of respiratory complications in patients receiving topical lignocaine
Scientific title
Incidence of respiratory complications in patients receiving topical lignocaine
Secondary ID [1] 297968 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory complications in patients receiving lignocaine 256963 0
Condition category
Condition code
Anaesthesiology 257106 257106 0 0
Anaesthetics

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Topical lignocaine spray onto the vocal cords during anaesthesia
Since this study is an observational study, the dose of lignocaine is not prescribed but will be recorded.
Observation period 1 year.
Intervention code [1] 256140 0
Not applicable
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258001 0
Incidence of respiratory complications intraoperatively and in the perioperative period with a particular interest on the complications post recommencing drinking and eating
Will be assessed by clinical monitoring.
Timepoint [1] 258001 0
intraoperatively until patient drinks and eats.
Secondary outcome [1] 263555 0
Nil
Timepoint [1] 263555 0
Nil

Eligibility
Key inclusion criteria
topical lignocaine onto the vocal cords during anaesthesia
Minimum age
No limit
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
hypersensitivity to lignocaine

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2010
Actual
18/11/2009
Date of last participant enrolment
Anticipated
Actual
15/04/2014
Date of last data collection
Anticipated
Actual
15/04/2014
Sample size
Target
200
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 256643 0
Hospital
Name [1] 256643 0
Princess Margaret Hospital for Children
Country [1] 256643 0
Australia
Primary sponsor type
Individual
Name
Britta Regli-von Ungern
Address
Department of Anaesthesia
Roberts Road
SUBIACO, WA 6008
Country
Australia
Secondary sponsor category [1] 255930 0
Individual
Name [1] 255930 0
Neil Chambers
Address [1] 255930 0
Department of Anaesthesia
Roberts Road
SUBIACO, WA 6008
Country [1] 255930 0
Australia

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 30929 0
Address 30929 0
Country 30929 0
Phone 30929 0
Fax 30929 0
Email 30929 0
Contact person for public queries
Name 14176 0
Britta Regli-von Ungern
Address 14176 0
Department of Anaesthesia
Roberts Road
SUBIACO, WA 6008
Country 14176 0
Australia
Phone 14176 0
+61893408222
Fax 14176 0
Email 14176 0
[email protected]
Contact person for scientific queries
Name 5104 0
Britta Regli-von Ungern
Address 5104 0
Department of Anaesthesia
Roberts Road
SUBIACO, WA 6008
Country 5104 0
Australia
Phone 5104 0
+61893408222
Fax 5104 0
Email 5104 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo The aim of the project was to investigate if there... [More Details]

Documents added automatically
No additional documents have been identified.