TolerancePhase 4LIDOGTCNCT02733471
Evaluation of the Efficacy and Safety of Administering Lidocaine Spray in Oesophago-gastro-duodenoscopy
A Phase 4 study testing Lidocaine in people with Tolerance, run by Basque Health Service at 1 site in Spain.
Trial summary
This study evaluates the efficacy and safety of the administration of lidocaine spray in oesophago-gastro-duodenoscopies. Half of the patients will receive lidocaine spray, while the other half will receive a placebo. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tolerance
- What is being tested?
- Lidocaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 586 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2016to May 2017
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged over 18
- ASA I, II and III
- Non allergic to lidocaine or any of the drugs used in the study
- Consent form signed by the patient
Who cannot join
- Stomach or esophagus diagnosed cancer
- Giant hiatal hernia diagnosed
- Zenker's diverticulum diagnosed
- Achalasia diagnosed
- Patients aged over 70
- Medical history of moderate to severe liver disease
Show all 15Show fewer
- Medical history of moderate to severe renal insufficiency
- Medical history of moderate to severe Obstructive Sleep Apnea Syndrome (OSA) (AHI≥15).
- Severe respiratory insufficiency(asmtha or COPD) diagnosed
- Patients with encephalopaty active
- Patients with medical history of methemoglobinemia
- Patients with history of drug abuse
- Patients with mental impairment
- Patients with BMI≥ 35
- Use of pediatric tube
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the efficacy and safety of the administration of lidocaine spray in oesophago-gastro-duodenoscopies. Half of the patients will receive lidocaine spray, while the other half will receive a placebo.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Experimental | Five lidocaine solution puffs (10mg lidocaine/puff) on the four posterior quadrants of the pharynx and on the base of the tongue, 3 minutes before the oesophago-gastro-duodenoscopy. Receives: Drug: Lidocaine |
| Control | Placebo comparator | Five placebo solution puffs on the four posterior quadrants of the pharynx and on the base of the tongue, 3 minutes before the oesophago-gastro-duodenoscopy Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of tolerance referred by the endoscopist in each group.
Establish degree of tolerance referred by the endoscopist in each group according to the scale defined by Leich et al ( Gastrointestinal Endosc 1993;39:384-7)
Measured: Up to 15 minutes after endoscopy
Secondary outcomes (9)
Degree of tolerance referred by the patient in each group
Establish degree of tolerance referred by the patient in each group according to the scale defined by Leich et al
Measured: Up to 15 minutes after endoscopy
Endoscopist's level of satisfaction with the procedure in each group
Endoscopist's level of satisfaction with the procedure according to a visual analogic scale
Measured: Up to 15 minutes after endoscopy
Patient's level of satisfaction with the procedure in each group.
Patient's level of satisfaction with the procedure according to a visual analogic scale
Measured: Up to 15 minutes after endoscopy
Number of completed procedures in control and lidocaine group
Number of completed procedures
Measured: Up to 15 minutes after endoscopy
Estimate the total dose of propofol used in each group
Dose of propofol used
Measured: 15 minutes before endoscopy
Establish and compare the number of adverse events detected in control and lidocaine group
Number of adverse events
Measured: Up to 15 minutes after endoscopy
Estimate the number of patients with retrograde amnesia in each group
Number of patients referring retrograde amnesia
Measured: Up to 15 minutes after endoscopy
Estimate the number of patients with cough in each group
Cough referred by the patient
Measured: Up to 15 minutes after endoscopy
Estimate the number of patients with oropharyngeal discomfort in each group.
Oropharyngeal discomfort referred by the patient
Measured: Up to 15 minutes after endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ToleranceStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 586 participants (actual)
Sponsor and investigators
- Lead sponsor
- Basque Health Service
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Irene Martin Marcos, Basque Health Service
- Investigators
- Irene Martin Marcos, RN, Principal investigator, Basque Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02733471
- Sponsor's protocol ID
- LIDOGTC
- Acronym
- LIDOGTC
- Status last verified
- Jan 2018
- First submitted
- 2 Mar 2016
- Last updated
- 29 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Martin-Marcos I, Fernandez-Morte N, Balsategui-Martin M, Ortiz-Cantero A, Bermudez-Ampudia C, Lopez-Picado A, Perez-Vaquero P, Salvador-Perez M, Cristobal-Dominguez E. Evaluation of pharyngeal lidocaine anesthesia for esophagogastroduodenoscopy: Double-blind randomized control trial. Dig Endosc. 2022 May;34(4):808-815. doi: 10.1111/den.14168. Epub 2021 Nov 17.
PubMed 34644419
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Administering Lidocaine Spray in Oesophago-gastro-duodenoscopy
- ClinicalTrials.gov ID
- NCT02733471
- Acronym / sponsor ID
- LIDOGTC / LIDOGTC
- Conditions
- Tolerance
- Keywords
- Lidocaine, Endoscopy, Tolerance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 586 participants (actual)
- Lead sponsor
- Basque Health ServiceOther government
- Study start
- Apr 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 11 Apr 2016 (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 evaluates the efficacy and safety of the administration of lidocaine spray in oesophago-gastro-duodenoscopies. Half of the patients will receive lidocaine spray, while the other half will receive a placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Experimental | Drug: LidocaineFive lidocaine solution puffs (10mg lidocaine/puff) on the four posterior quadrants of the pharynx and on the base of the tongue, 3 minutes before the oesophago-gastro-duodenoscopy. |
| Control | Placebo comparator | Drug: PlaceboFive placebo solution puffs on the four posterior quadrants of the pharynx and on the base of the tongue, 3 minutes before the oesophago-gastro-duodenoscopy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged over 18
- ASA I, II and III
- Non allergic to lidocaine or any of the drugs used in the study
- Consent form signed by the patient
Key exclusion criteria (15 listed)
- Stomach or esophagus diagnosed cancer
- Giant hiatal hernia diagnosed
- Zenker's diverticulum diagnosed
- Achalasia diagnosed
- Patients aged over 70
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 | Drug | Lidocaine |
| PlaceboPlacebo | Drug | Control |
Primary outcome
Degree of tolerance referred by the endoscopist in each group.
Time frame: Up to 15 minutes after endoscopy
Establish degree of tolerance referred by the endoscopist in each group according to the scale defined by Leich et al ( Gastrointestinal Endosc 1993;39:384-7)
9 secondary outcomes
Degree of tolerance referred by the patient in each group
Time frame: Up to 15 minutes after endoscopy
Endoscopist's level of satisfaction with the procedure in each group
Time frame: Up to 15 minutes after endoscopy
Patient's level of satisfaction with the procedure in each group.
Time frame: Up to 15 minutes after endoscopy
Number of completed procedures in control and lidocaine group
Time frame: Up to 15 minutes after endoscopy
Estimate the total dose of propofol used in each group
Time frame: 15 minutes before endoscopy
Establish and compare the number of adverse events detected in control and lidocaine group
Time frame: Up to 15 minutes after endoscopy
Estimate the number of patients with retrograde amnesia in each group
Time frame: Up to 15 minutes after endoscopy
Estimate the number of patients with cough in each group
Time frame: Up to 15 minutes after endoscopy
Estimate the number of patients with oropharyngeal discomfort in each group.
Time frame: Up to 15 minutes after endoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2018.
- Derived from this study: PubMed 34644419Martin-Marcos I, Fernandez-Morte N, Balsategui-Martin M, Ortiz-Cantero A, Bermudez-Ampudia C, Lopez-Picado A, Perez-Vaquero P, Salvador-Perez M, Cristobal-Dominguez E. Evaluation of pharyngeal lidocaine anesthesia for esophagogastroduodenoscopy: Double-blind randomized control trial. Dig Endosc. 2022 May;34(4):808-815. doi: 10.1111/den.14168. Epub 2021 Nov 17.
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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.
Irene Martin Marcos, RN principal investigator
Basque Health System
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 in people with Tolerance, run by Basque Health Service at 1 site in Spain.
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 4 inclusion and 15 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: finished, as of the sponsor's last update on 29 Jan 2018. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of tolerance referred by the endoscopist in each group. (time frame: Up to 15 minutes after endoscopy). 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 NCT02733471, which also lists 1 linked publication.
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 29 Jan 2018.