Anesthetics, LocalPhase 4LIDOGASNCT04725695
Preoperative Viscous Lidocaine for Upper Gastrointestinal Endoscopy
A Phase 4 study testing Viscous Lidocaine in people with Anesthetics, Local and Esophagogastroduodenoscopy, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
In this randomized placebo-controlled clinical trial, patients will be randomized to be administered viscous lidocaine or placebo preoperatively to elective upper GI endoscopy Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anesthetics, Local, Esophagogastroduodenoscopy
- What is being tested?
- Viscous Lidocaine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 1 siteDenmark
- Study dates
- 29 Mar 2022to 30 Oct 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients referred to and found fit for upper GI endoscopy in an out patient setting
- Between 18 and 75 years old
- Speaks and understands Danish
Who cannot join
- Patients admitted for upper GI endoscopy in an in-patient setting
- Patients with dementia and/or other cognitive dysfunction disorders
- Patients primarily complaining of dysphagia
- Patients allergic to lidocaine
- Patients with suspected retention
- Patients who will undergo upper GI endoscopy with nurse-assisted propofol sedation
- Patients who will undergo upper GI endoscopy with assistance of anesthesia-personnel
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Endoscopy, Digestive Disease Center, Bispebjerg Hospital
Copenhagen, 2400
About this study
Official title: Preoperative Viscous Lidocaine for Upper Gastrointestinal Endoscopy - a Blinded, Randomized, Placebo-controlled Clinical Trial
In this randomized placebo-controlled clinical trial, patients will be randomized to be administered viscous lidocaine or placebo preoperatively to elective upper GI endoscopy
- Conditions
- Anesthetics, Local, Esophagogastroduodenoscopy
- Being tested
- Viscous Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viscous LidocaineDrug
The patients will be randomized to either viscous lidocaine or placebo
| Study group | Role | What they receive |
|---|---|---|
| Viscous lidocaine | Experimental | Oral viscous lidocaine 20 mg/ml, 10 ml Receives: Drug: Viscous Lidocaine |
| Placebo | Placebo comparator | Oral viscous solution without active drug, 10 ml Receives: Drug: Viscous Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease of intubation
The endoscopist will rate the difficulty of intubating the esophagus on a numeric rating scale (NRS) from 0 (worst) to 10 (best)
Measured: Immediately after the procedure
Secondary outcomes (8)
Ease of examination
The endoscopist will rate the difficulty of performing the endoscopy on a numeric rating scale (NRS) from 0 (worst) to 10 (best)
Measured: Immediately after the procedure
Number of intubation attempts
Total number of intubation attempts until the esophagus is reached
Measured: Peroperatively counted by the assisting nurse
Number of gag reflexes
Total number of gag reflexes during the examination
Measured: Peroperatively counted by the assisting nurse
Patient's perception of discomfort
The patient's self-evaluation of discomfort during the examination on a numeric rating scale (NRS) from 0 (worst) to 10 (best)
Measured: Immediately after the procedure
Patient's willingness to be reexamined
The patient's willingness to have the procedure performed again in the future on a numeric rating scale (NRS) from 0 (worst) to 10 (best)
Measured: Immediately after the procedure
Sedation 1
Number of milligrams midazolam administered during the procedure
Measured: Peroperatively
Sedation 2
Number of milligrams alfentanil administered during the procedure
Measured: Peroperatively
Perception of gag reflexes
The endoscopist's rating of the patient's degree of gag reflexes, numeric rating scale (NRS) from 0 (worst) to 10 (best)
Measured: Immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start29 Mar 2022
- Primary completion15 Dec 2023
- Study completion30 Oct 2024
Why it stopped: Lack of ressources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthetics, LocalStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erling Oma, Bispebjerg Hospital
- Investigators
- Erling Oma, MD, PhD, Principal investigator, Digestive Disease Center, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725695
- Sponsor's protocol ID
- 2020-005177-27
- Acronym
- LIDOGAS
- Status last verified
- Feb 2025
- First submitted
- 19 Jan 2021
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Viscous Lidocaine for Upper Gastrointestinal Endoscopy - a Blinded, Randomized, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04725695
- Acronym / sponsor ID
- LIDOGAS / 2020-005177-27
- Conditions
- Anesthetics, Local, Esophagogastroduodenoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of ressources
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 29 Mar 2022 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 27 Jan 2021 (actual)
- 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.
In this randomized placebo-controlled clinical trial, patients will be randomized to be administered viscous lidocaine or placebo preoperatively to elective upper GI endoscopy
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Viscous lidocaine | Experimental | Drug: Viscous LidocaineOral viscous lidocaine 20 mg/ml, 10 ml |
| Placebo | Placebo comparator | Drug: Viscous LidocaineOral viscous solution without active drug, 10 ml |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients referred to and found fit for upper GI endoscopy in an out patient setting
- Between 18 and 75 years old
- Speaks and understands Danish
Key exclusion criteria (7 listed)
- Patients admitted for upper GI endoscopy in an in-patient setting
- Patients with dementia and/or other cognitive dysfunction disorders
- Patients primarily complaining of dysphagia
- Patients allergic to lidocaine
- Patients with suspected retention
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 |
|---|---|---|
| Viscous LidocaineThe patients will be randomized to either viscous lidocaine or placebo | Drug | Placebo, Viscous lidocaine |
Primary outcome
Ease of intubation
Time frame: Immediately after the procedure
The endoscopist will rate the difficulty of intubating the esophagus on a numeric rating scale (NRS) from 0 (worst) to 10 (best)
8 secondary outcomes
Ease of examination
Time frame: Immediately after the procedure
Number of intubation attempts
Time frame: Peroperatively counted by the assisting nurse
Number of gag reflexes
Time frame: Peroperatively counted by the assisting nurse
Patient's perception of discomfort
Time frame: Immediately after the procedure
Patient's willingness to be reexamined
Time frame: Immediately after the procedure
Sedation 1
Time frame: Peroperatively
Sedation 2
Time frame: Peroperatively
Perception of gag reflexes
Time frame: Immediately after the procedure
Results and safety
The study was stopped early (reason given: Lack of ressources). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: Yes
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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.
Erling Oma, MD, PhD principal investigator
Digestive Disease Center, Bispebjerg 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 Viscous Lidocaine in people with Anesthetics, Local and Esophagogastroduodenoscopy, run by Bispebjerg Hospital at 1 site in Denmark.
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 7 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: stopped early, as of the sponsor's last update on 6 Feb 2025. 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 Denmark. 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 was stopped early (reason given: Lack of ressources). Results are not available in the source record.
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?
Ease of intubation (time frame: Immediately after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2025.