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Trial registered on ANZCTR


Registration number
ACTRN12611000143921
Ethics application status
Approved
Date submitted
26/01/2011
Date registered
8/02/2011
Date last updated
26/02/2019
Date data sharing statement initially provided
26/02/2019
Date results information initially provided
26/02/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness of xylocaine spray in upper gastrointestinal endoscopy
Scientific title
The effect of 10% xylocaine spray compared to a placebo on ease of endoscopy and hemodynamic changes in patients admitted for upper gastrointestinal endoscopy under deep sedation with total intravenous anesthesia
Secondary ID [1] 253458 0
Chang Gung Memorial Hospital IRB 99-2135A3
Universal Trial Number (UTN)
U1111-1119-2009
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
aspiration pneumonia 261010 0
methemoglobinemia 261011 0
anaphylaxis 261012 0
Condition category
Condition code
Anaesthesiology 259145 259145 0 0
Anaesthetics
Oral and Gastrointestinal 259258 259258 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients are randomly assigned to have 10% lidocaine spray (approximately 30mg) or normal saline in their throat on arrival, approximately 3 minutes before upper gastrointestinal endoscopy.
Intervention code [1] 257900 0
Prevention
Intervention code [2] 257982 0
Treatment: Drugs
Comparator / control treatment
normal saline is sprayed onto patients throats before endoscopy
Control group
Placebo

Outcomes
Primary outcome [1] 261997 0
The overall ease of the endoscopy assessed by endoscopists via rating scales.
Rating scales are used to assess by endoscopists. The parameters include patients' ability to follow verbal command, show somatic response after anesthesia, have any coughs, hiccups, or gag reflex on esophageal intubation and also the overall ease of esophageal intubation and satification of the procedure by endoscopists.
Timepoint [1] 261997 0
at the end of the endoscopy
Secondary outcome [1] 268930 0
Hemodynamic changes during endoscopy (eg heart rate, non-invasive blood pressure, oxygen saturation on 3L oxygen nasal prong, BIS index) and the requirement of airway maneuver
Timepoint [1] 268930 0
The hemodynamic values (HR, BP, BIS, SpO2) are recorded on arrival, then every 2 min afterwards during endoscopy and again on departure.

Eligibility
Key inclusion criteria
1. All participants who sign the consent and agreement form
2. All participants who are admitted for upper gastrointestinal endoscopy under general anesthesia with total intravenous anesthesia
3. All participants who are between the age of 20 and 69
Minimum age
20 Years
Maximum age
69 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. young age <20 years; old age >69 years
2. participants who are reported to have allergic reaction to the anesthetic agents used in the study (lidocaine)
3. pregnant women or who are breastfeeding
4. participants who are deemed to have significant higher risk if enrolled in the study (eg severe obstructive sleep apnea)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients who fullfill the inclusion criteria are recruited. The consented participants are allocated to have either lidocaine spray or normal saline spray sprayed onto their throat before the endoscopy via a central randomization by computer . Both the patients and endoscopists are blinded whereas the anesthetist on site is to administer the spray and is aware of the allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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 outside Australia
Country [1] 3151 0
Taiwan, Province Of China
State/province [1] 3151 0
Country [2] 3152 0
Taiwan, Province Of China
State/province [2] 3152 0
Taiwan

Funding & Sponsors
Funding source category [1] 258373 0
Hospital
Name [1] 258373 0
Chang Gung Memorial Hospital
Address [1] 258373 0
No.5, Fusing St., Gueishan Township, Taoyuan County 333, Taiwan (R.O.C.)
Country [1] 258373 0
Taiwan, Province Of China
Primary sponsor type
Hospital
Name
Chang Gung Memorial Hospital
Address
No.5, Fusing St., Gueishan Township, Taoyuan County 333, Taiwan (R.O.C.)
Country
Taiwan, Province Of China
Secondary sponsor category [1] 257521 0
None
Name [1] 257521 0
Address [1] 257521 0
Country [1] 257521 0
Other collaborator category [1] 251781 0
Individual
Name [1] 251781 0
Tsai, Yung-Fung
Address [1] 251781 0
No.5, Fusing St., Gueishan Township, Taoyuan County 333, Taiwan (R.O.C.)
Country [1] 251781 0
Taiwan, Province Of China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260350 0
Chang Gung Memorial Hospital Institutional Review Board
Ethics committee address [1] 260350 0
No.5, Fusing St., Gueishan Township, Taoyuan County 333, Taiwan (R.O.C.)
Ethics committee country [1] 260350 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 260350 0
29/07/2010
Approval date [1] 260350 0
29/09/2010
Ethics approval number [1] 260350 0

Summary
Brief summary
The use of topical pharyngeal anesthesia has long been controversial among the anesthetists and no evidence has well supported the use of the spray. The use of lidocaine spray is not without adverse effects, which include aspiration pneumonia, methemoglobinemia and anaphylaxis. Most of the patients undergo endoscopies under general anesthesia and theoretically should not require pharngeal spray to suppress pharyngeal reflexes during the procedure. The aim of the study is determine whether the use of the spray is necessary in patients under deep sedation/general anesthesia. Deep sedation is achieved by total intravenous anesthesia (TIVA) with propofol.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32123 0
Dr Cynthia Tsai
Address 32123 0
Hsin-I Tsai
No.5, Fusing St., Gueishan Township, Taoyuan County 333, Taiwan (R.O.C.)
Country 32123 0
Taiwan, Province Of China
Phone 32123 0
886-975366364
Fax 32123 0
Email 32123 0
tsaic@hotmail.com
Contact person for public queries
Name 15370 0
Dr Cynthia Tsai
Address 15370 0
No.5, Fusing St., Gueishan Township, Taoyuan County 333, Taiwan (R.O.C.)
Country 15370 0
Taiwan, Province Of China
Phone 15370 0
886-975366364
Fax 15370 0
Email 15370 0
tsaic@hotmail.com
Contact person for scientific queries
Name 6298 0
Dr Cynthia Tsai
Address 6298 0
No.5, Fusing St., Gueishan Township, Taoyuan County 333, Taiwan (R.O.C.)
Country 6298 0
Taiwan, Province Of China
Phone 6298 0
886/975366364
Fax 6298 0
Email 6298 0
tsaic@hotmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Statistical analysis plan
Informed consent form
Ethical approval
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 1356 0
Dig Dis Sci (2012) 57:2519-2526
DOI 10.1007/s10620-012-2206-4
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary