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Trial registered on ANZCTR


Registration number
ACTRN12620000023954
Ethics application status
Approved
Date submitted
31/10/2019
Date registered
15/01/2020
Date last updated
24/01/2022
Date data sharing statement initially provided
15/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Lignocaine in gastroscopy
Scientific title
LIG Trial - Lignocaine in gastroscopy and the effect on time to eye opening.
Secondary ID [1] 299687 0
Nil known
Universal Trial Number (UTN)
U1111-1242-8429
Trial acronym
LIG
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
pain 315040 0
Condition category
Condition code
Anaesthesiology 313370 313370 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group: 1.5mg/kg lignocaine/lidocaine to maximum dose of 120mg as a bolus dose, prior to gastroscopy, via intravenous administration, administered by anaesthetist.

The injection of the 'intervention drug' will be given prior to the induction drug of propofol, preferably as soon as IV cannula is inserted. If the gastroscopy is still proceeding after 20 minutes, a further dose of the 'intervention drug' will be given (either NaCl 0.9% or 1.5mg/kg of lignocaine not exceeding a total dose of 3mg/kg lignocaine). (Please note, patients who are having a simultaneous colonoscopy will not be included.)

Strategies to monitor adherence: independent researcher to note that the 'intervention drug' (1x10ml syringe of 10ml NaCl 0.9% or lignocaine 1.5mg/kg up to maximum dose of 120mg bolus) is given prior to induction.

A gastroscopy involves insertion of a gastroscope (a semi rigid telescope with a camera on the end) which is inserted by the gastroenterologist into the mouth and terminating in the small bowel via the stomach and oesophagus. This procedure usually done under sedation in Australia with the assistance of an anaesthetist. The procedure duration is usually under 10 minutes and rarely exceeds 30 minutes. For further information, please refer to this website:https://healthywa.wa.gov.au/Articles/F_I/Gastroscopy-endoscopy
Intervention code [1] 315954 0
Treatment: Drugs
Comparator / control treatment
Control group: up to 12mls of normal saline given instead. Double blinded randomised controlled trial.
Intravenous bolus dose of normal saline 0.9%
Control group
Placebo

Outcomes
Primary outcome [1] 321851 0
Time to eye opening - clinical observation measured in seconds by researcher using a timer.
Timepoint [1] 321851 0
Immediately post procedure
Secondary outcome [1] 376473 0
Gastroscopy insertion conditions as determined by the Gastroenterologist via clinical observation using a validated assessment tool.: CLINICIAN SATISFACTION WITH SEDATION INSTRUMENT (CSSI) - Items 17-21 - Global satisfaction rating
Timepoint [1] 376473 0
Immediately after the gastroscope is inserted, the Gastroenterologist will be asked to rate gastroscope intubation conditions (of ease of the gastroscope insertion into the oesophagus)
Secondary outcome [2] 376474 0
Time until discharge from recovery - as recorded from the patient's medical record.
Timepoint [2] 376474 0
Measured from the time the patient's gastroscopy is completed until the patient leaves the recovery room. (Usually stage 3 recovery for discharge home)
Secondary outcome [3] 376475 0
Pain score post procedure - Visual analogue scale rating - 1-10
Timepoint [3] 376475 0
Measured immediately post procedure

Eligibility
Key inclusion criteria
Adults (greater than or equal to 18 years) undergoing elective outpatient gastroscopy with low aspiration risk.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient refusal
2 After-hours or emergency gastroscopies including indications for upper gastrointestinal bleed.
3 Contraindication or allergy to lignocaine.
4 <18 years old or >80 years old
5. Pregnant patients
6. Patients at high risk for aspiration or requiring intubation
7. Gastroscopy solely performed by topicalisation of the throat
8. Patients requiring opioids during gastroscopy

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)
central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Single centre
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power calculation has been increased to 100 patients. Approximately 44 in each of the control and intervention group.

Sample size estimation: Power calculation: Assuming mean (SD): 10.0 (5.0) vs. 7 (5.0), alpha 0.05, beta 0.20 (power 80%), need 44 per group. Therefore 100 enrolled.
Assumptions: time to wake up likely to be within minutes between the control and intervention group.
Standard deviation 1-3 minutes

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/01/2020
Actual
16/06/2020
Date of last participant enrolment
Anticipated
1/02/2022
Actual
9/11/2021
Date of last data collection
Anticipated
1/02/2022
Actual
9/11/2021
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15083 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 28379 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 304166 0
Self funded/Unfunded
Name [1] 304166 0
Dr Olivia Leahy
Country [1] 304166 0
Australia
Funding source category [2] 304290 0
Hospital
Name [2] 304290 0
Alfred Health
Country [2] 304290 0
Australia
Primary sponsor type
Hospital
Name
Alfred health
Address
55 Commercial Rd, Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 304394 0
None
Name [1] 304394 0
Address [1] 304394 0
Country [1] 304394 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304641 0
The Alfred Ethics Committee
Ethics committee address [1] 304641 0
55 Commercial Rd, Melbourne VIC 3004
Ethics committee country [1] 304641 0
Australia
Date submitted for ethics approval [1] 304641 0
01/11/2019
Approval date [1] 304641 0
13/01/2020
Ethics approval number [1] 304641 0
Project Number: HREC/58991/Alfred-2019 (Local Reference: Project 662/19)

Summary
Brief summary
The aim of this randomised controlled trial is to determine whether the use of a therapeutic dose of lignocaine enhances elective outpatient gastroscopy episodes as measured by time to eye opening, gastroscope insertion conditions, time from patient discharge from recovery and patient comfort (measured by a pain score).

Hypothesis: Lignocaine is a local anaesthetic which may assist with improved endoscope insertion conditions, less post gastroscopy discomfort and faster time to wake-up and discharge from the post-anaesthetic recovery unit (PACU).
Trial website
Nil known
Trial related presentations / publications
Not applicable
Public notes

Contacts
Principal investigator
Name 97690 0
Prof Paul Myles
Address 97690 0
The Alfred, 55 Commercial Rd, Melbourne VIC 3004
Country 97690 0
Australia
Phone 97690 0
+61 397062000
Fax 97690 0
+61 3 9076 2222
Email 97690 0
[email protected]
Contact person for public queries
Name 97691 0
Olivia Leahy
Address 97691 0
The Alfred, 55 Commercial Rd, Melbourne VIC 3004
Country 97691 0
Australia
Phone 97691 0
+61 3 90762000
Fax 97691 0
+61 3 9076 2222
Email 97691 0
[email protected]
Contact person for scientific queries
Name 97692 0
Olivia Leahy
Address 97692 0
The Alfred, 55 Commercial Rd, Melbourne VIC 3004
Country 97692 0
Australia
Phone 97692 0
+61 390762000
Fax 97692 0
+61 3 9076 2222
Email 97692 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
Patient data will be de-indentified post randomisation, for data collection and analysis. Data only re-identifiable by investigating team and will not be made available for public viewing.


What supporting documents are/will be available?




Results publications and other study-related documents

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