DysphagiaNCT02620501
Does Use of Topical Lidocaine in EGD Reduce Amount of IV Midazolam and Fentanyl Required and Shorten Recovery Time
A study testing Lidocaine in people with Dysphagia and GERD, run by Brooke Army Medical Center at 1 site in United States.
Trial summary
Patients will be randomized to a placebo or study group who will receive topical lidocaine prior to EGD. Amount of medication used, recovery time, patient/endoscopist satisfaction will then be assessed. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Dysphagia, GERD, Abdominal Pain
- What is being tested?
- Lidocaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to May 2016
- Phase
- Interventional
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- EGD alone performed by staff gastroenterologist as an outpatient
- Between the age of 18 and 89
- Not requiring anesthesia support or use of medications other than fentanyl and midazolam
Who cannot join
- Prior history of head and neck surgery
- Known hypersensitivity to local anesthetics, the amide type or any components of the topical lidocaine
- Patients having interventions other than polypectomy performed
- Pregnant or breast feeding females
- Patients with severe liver impairment
- Known hypersensitivity to benzodiazepine or fentanyl
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Brooke Army Medical Center
Fort Sam Houston, Texas, 78219
Adam M Tritsch, MD
About this study
Official title: Does Topical Lidocaine Reduce The Amount of Intravenous Conscious Sedation Required To Complete Diagnostic Upper Endoscopy and Shorten Recovery Time? A Double Blinded, Randomized, Placebo Controlled Study.
Patients will be randomized to a placebo or study group who will receive topical lidocaine prior to EGD. Amount of medication used, recovery time, patient/endoscopist satisfaction will then be assessed.
Read the detailed description
The study will be a double blinded randomized placebo controlled trial
Patients between 18 and 89 years old who are scheduled for EGD may be eligible to enroll in the study. Potential subjects will be sought through referral by their treating attending and fellow gastroenterologist, who will be apprised of the inclusion and exclusion criteria. Patients possibly meeting inclusive and exclusive criteria will be approached and discussed the study further with the investigators. Those expressing a desire to participate in the study will be given written informed consent prior to participation. The investigators will enroll patients into the study with a goal of at least 53 patients in each group which is the number of patients our statistician recommended to appropriately power our study.
Patients who consent to enroll in the study will be randomized into 2 groups. Group 1: Swish and swallow 10ml of 2% lidocaine solution Group 2: Swish and swallow 10ml of 0.45% sodium chloride solution
The patients will then undergo endoscopy for the indication identified in their clinic appointment. Following the procedure, patients will be taken to the recovery area and recovered per clinic protocol. The endoscopist will complete a satisfaction questionnaire. The day following the procedure a nurse will call to check for post-operative complications per clinic protocol. The day following, an investigator will also call to perform a patient satisfaction survey..
- Conditions
- Dysphagia, GERD, Abdominal Pain
- Being tested
- Lidocaine, Placebo
- Keywords
- EGD, topical lidocaine, recovery time, intravenous sedation
- Medical subject headings
- Deglutition Disorders, Gastroesophageal Reflux, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
topical lidocaine
PlaceboDrug
0.45% Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Patients will receive 10cc of 1/2 normal saline to gargle prior to EGD Receives: Drug: Placebo |
| Experimental | Experimental | Patients will receive 10cc of 2% topical lidocaine to gargle prior to EGD Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of sedation used
We will record the amount of sedation used during the procedure
Measured: 60 minutes
Secondary outcomes (2)
Recovery time
We will record the amount of time it takes to recover following the procedure
Measured: 120 minutes
Patient and physician satisfaction
We will assess patient and physician satisfaction with the procedure through use of a questionaire
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startJul 2015
- Primary completionFeb 2016 (estimated)
- Study completionMay 2016 (estimated)
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 DysphagiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Adam Tritsch, Brooke Army Medical Center
- Investigators
- Adam M Tritsch, MD, Principal investigator, Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02620501
- Sponsor's protocol ID
- BrookeAMC
- Status last verified
- Dec 2015
- First submitted
- 26 Jan 2015
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Davis DE, Jones MP, Kubik CM. Topical pharyngeal anesthesia does not improve upper gastrointestinal endoscopy in conscious sedated patients. Am J Gastroenterol. 1999 Jul;94(7):1853-6. doi: 10.1111/j.1572-0241.1999.01217.x.
PubMed 10406247
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Topical Lidocaine Reduce The Amount of Intravenous Conscious Sedation Required To Complete Diagnostic Upper Endoscopy and Shorten Recovery Time? A Double Blinded, Randomized, Placebo Controlled Study.
- ClinicalTrials.gov ID
- NCT02620501
- Acronym / sponsor ID
- BrookeAMC
- Conditions
- Dysphagia, GERD, Abdominal Pain
- Keywords
- EGD, topical lidocaine, recovery time, intravenous sedation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Study start
- Jul 2015
- Primary completion
- Feb 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 3 Dec 2015 (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.
Patients will be randomized to a placebo or study group who will receive topical lidocaine prior to EGD. Amount of medication used, recovery time, patient/endoscopist satisfaction will then be assessed.
Detailed description
The study will be a double blinded randomized placebo controlled trial
Patients between 18 and 89 years old who are scheduled for EGD may be eligible to enroll in the study. Potential subjects will be sought through referral by their treating attending and fellow gastroenterologist, who will be apprised of the inclusion and exclusion criteria. Patients possibly meeting inclusive and exclusive criteria will be approached and discussed the study further with the investigators. Those expressing a desire to participate in the study will be given written informed consent prior to participation. The investigators will enroll patients into the study with a goal of at least 53 patients in each group which is the number of patients our statistician recommended to appropriately power our study.
Patients who consent to enroll in the study will be randomized into 2 groups. Group 1: Swish and swallow 10ml of 2% lidocaine solution Group 2: Swish and swallow 10ml of 0.45% sodium chloride solution
The patients will then undergo endoscopy for the indication identified in their clinic appointment. Following the procedure, patients will be taken to the recovery area and recovered per clinic protocol. The endoscopist will complete a satisfaction questionnaire. The day following the procedure a nurse will call to check for post-operative complications per clinic protocol. The day following, an investigator will also call to perform a patient satisfaction survey..
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPatients will receive 10cc of 1/2 normal saline to gargle prior to EGD |
| Experimental | Experimental | Drug: LidocainePatients will receive 10cc of 2% topical lidocaine to gargle prior to EGD |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- EGD alone performed by staff gastroenterologist as an outpatient
- Between the age of 18 and 89
- Not requiring anesthesia support or use of medications other than fentanyl and midazolam
Key exclusion criteria (6 listed)
- Prior history of head and neck surgery
- Known hypersensitivity to local anesthetics, the amide type or any components of the topical lidocaine
- Patients having interventions other than polypectomy performed
- Pregnant or breast feeding females
- Patients with severe liver impairment
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 |
|---|---|---|
| Lidocainetopical lidocaine | Drug | Experimental |
| Placebo0.45% Normal Saline | Drug | Placebo |
Primary outcome
Amount of sedation used
Time frame: 60 minutes
We will record the amount of sedation used during the procedure
2 secondary outcomes
Recovery time
Time frame: 120 minutes
Patient and physician satisfaction
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
- Background: PubMed 10406247Davis DE, Jones MP, Kubik CM. Topical pharyngeal anesthesia does not improve upper gastrointestinal endoscopy in conscious sedated patients. Am J Gastroenterol. 1999 Jul;94(7):1853-6. doi: 10.1111/j.1572-0241.1999.01217.x.
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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.
Adam M Tritsch, MD principal investigator
Brooke Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine in people with Dysphagia and GERD, run by Brooke Army Medical Center at 1 site in United States.
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 6 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 3 Dec 2015. 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 United States. 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.
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 Adam M Tritsch, MD (210-916-4367, adam.m.tritsch.mil@mail.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of sedation used (time frame: 60 minutes). 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 NCT02620501, 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 3 Dec 2015.