Anesthesia of Mucous MembranePhase 4NCT02317770
Comparison of Topical and Nebulized Anesthesia in Patients Undergoing Esophago-Gastro-Duodenoscopy
A Phase 4 study testing Lidocaine Spray and Nebulized Lidocaine in people with Anesthesia of Mucous Membrane, run by Mahidol University at 1 site in Thailand.
Trial summary
This study compares the effect of nebulized lidocaine and lidocaine spray in patients undergoing esophago-gastro-duodenoscopy. The investigators evaluate the success rate of the procedure between two methods. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia of Mucous Membrane
- What is being tested?
- Lidocaine Spray and Nebulized Lidocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteThailand
- Study dates
- Nov 2013to Apr 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective case for esophago-gastro-duodenoscopy with ASA classification 1-2
- Both genders
- Age between 18-65 years
Who cannot join
- History of smoking
- Upper respiratory tract infection
- Asthma
- Heart disease
- Allergy to local anesthetic drugs
- Withdrawal or termination criteria
Show all 10Show fewer
- Patient refusal
- Patient develops lidocaine allergy
- Bronchospasm
- Sign of Local Anesthetic Toxicity
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine Siriraj Hospital
Bangkoknoi, Bangkok, 10700
Papiroon Noitasaeng, RN, 66(81)4930935, papiroonnoi@gmail.com
About this study
This study compares the effect of nebulized lidocaine and lidocaine spray in patients undergoing esophago-gastro-duodenoscopy. The investigators evaluate the success rate of the procedure between two methods.
Read the detailed description
This is a randomized-controlled trial in the patients undergoing esophago-gastro-duodenoscopy. The patients are randomized by computer into two arms: nebulized lidocaine and lidocaine spray. Both drugs are applied 15-20 minutes prior the prior the procedure. Only one endoscopist participate in this study. After the procedure finishes, the investigators evaluate the outcome and satisfaction of patients and endoscopist.
- Conditions
- Anesthesia of Mucous Membrane
- Being tested
- Lidocaine Spray, Nebulized Lidocaine
- Keywords
- lidocaine, esophago-gastro-duodenoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine SprayDrug
Also called Xylocaine Spray
5 puffs of 10% Lidocaine spray is administered every 5 minutes for 4 times. Then the patient is undergone procedure 5 minutes later.
Nebulized LidocaineDrug
Also called Nebulized Xylocaine
The patient receives 2.5 mL of 10% lidocaine is used by nebulizer under oxygen flow 6-7 LPM for 15 minutes prior the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine Spray | Active comparator | 20 puffs of 10% Lidocaine spray Receives: Drug: Lidocaine Spray |
| Nebulized Lidocaine | Active comparator | 2.5 mL of 10% Lidocaine Receives: Drug: Nebulized Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Topical and Nebulized Anesthesia
Both nurse anesthetist and endoscopist evaluate difficulty during the procedure and demand for additional sedative drugs using numeric scale
Measured: 90 min
Secondary outcomes (2)
Patient Satisfaction
Satisfaction is evaluated using Numeric Rating Scale (0-10)
Measured: 90 min
Operator Satisfaction
Satisfaction is evaluated using Numeric Rating Scale (0-10)
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2014 (estimated)
- Study startNov 2013
- Primary completionMar 2016
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anesthesia of Mucous MembraneStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Papiroon Noitasaeng, RN, Principal investigator, Department of Anesthesia, Faculty of Medicine Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02317770
- Sponsor's protocol ID
- SI534/2013
- Status last verified
- Mar 2016
- First submitted
- 11 Dec 2014
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Korttila K, Tarkkanen J, Tarkkanen L. Comparison of laryngotracheal and ultrasonic nebulizer administration of lidocaine in local anaesthesia for bronchoscopy. Acta Anaesthesiol Scand. 1981 Apr;25(2):161-5. doi: 10.1111/j.1399-6576.1981.tb01628.x.
PubMed 7324824Dhir V, Swaroop VS, Vazifdar KF, Wagle SD. Topical pharyngeal anesthesia without intravenous sedation during upper gastrointestinal endoscopy. Indian J Gastroenterol. 1997 Jan;16(1):10-1.
PubMed 9167371
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Topical and Nebulized Anesthesia in Patients Undergoing Esophago-Gastro-Duodenoscopy
- ClinicalTrials.gov ID
- NCT02317770
- Acronym / sponsor ID
- SI534/2013
- Conditions
- Anesthesia of Mucous Membrane
- Keywords
- lidocaine, esophago-gastro-duodenoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (estimated)
- First posted
- 16 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares the effect of nebulized lidocaine and lidocaine spray in patients undergoing esophago-gastro-duodenoscopy. The investigators evaluate the success rate of the procedure between two methods.
Detailed description
This is a randomized-controlled trial in the patients undergoing esophago-gastro-duodenoscopy. The patients are randomized by computer into two arms: nebulized lidocaine and lidocaine spray. Both drugs are applied 15-20 minutes prior the prior the procedure. Only one endoscopist participate in this study. After the procedure finishes, the investigators evaluate the outcome and satisfaction of patients and endoscopist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine Spray | Active comparator | Drug: Lidocaine Spray20 puffs of 10% Lidocaine spray |
| Nebulized Lidocaine | Active comparator | Drug: Nebulized Lidocaine2.5 mL of 10% Lidocaine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- elective case for esophago-gastro-duodenoscopy with ASA classification 1-2
- Both genders
- Age between 18-65 years
Key exclusion criteria (10 listed)
- History of smoking
- Upper respiratory tract infection
- Asthma
- Heart disease
- Allergy to local anesthetic drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine SprayAlso: Xylocaine Spray5 puffs of 10% Lidocaine spray is administered every 5 minutes for 4 times. Then the patient is undergone procedure 5 minutes later. | Drug | Lidocaine Spray |
| Nebulized LidocaineAlso: Nebulized XylocaineThe patient receives 2.5 mL of 10% lidocaine is used by nebulizer under oxygen flow 6-7 LPM for 15 minutes prior the procedure. | Drug | Nebulized Lidocaine |
Primary outcome
Comparison of Topical and Nebulized Anesthesia
Time frame: 90 min
Both nurse anesthetist and endoscopist evaluate difficulty during the procedure and demand for additional sedative drugs using numeric scale
2 secondary outcomes
Patient Satisfaction
Time frame: 90 min
Operator Satisfaction
Time frame: 30 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
- Background: PubMed 7324824Korttila K, Tarkkanen J, Tarkkanen L. Comparison of laryngotracheal and ultrasonic nebulizer administration of lidocaine in local anaesthesia for bronchoscopy. Acta Anaesthesiol Scand. 1981 Apr;25(2):161-5. doi: 10.1111/j.1399-6576.1981.tb01628.x.
- Background: PubMed 9167371Dhir V, Swaroop VS, Vazifdar KF, Wagle SD. Topical pharyngeal anesthesia without intravenous sedation during upper gastrointestinal endoscopy. Indian J Gastroenterol. 1997 Jan;16(1):10-1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Papiroon Noitasaeng, RN principal investigator
Department of Anesthesia, Faculty of Medicine Siriraj Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine Spray and Nebulized Lidocaine in people with Anesthesia of Mucous Membrane, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Papiroon Noitasaeng, RN (66(81)4930935, papiroonnoi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Topical and Nebulized Anesthesia (time frame: 90 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02317770, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2016.