C.Medical Procedure; Digestive SystemNCT02307773
Lidocaine Spray on an Endoscope to Improve Tolerance to Endoscopy
An observational study of C.Medical Procedure; Digestive System and Disorder of Upper Gastrointestinal Tract, run by Cheju Halla General Hospital at 1 site in South Korea.
Trial summary
The investigators tested whether a new method which additional lidocaine spray on the tip of endoscope can increase the tolerance of examinee during endoscopy than conventional pharyngeal anesthesia alone. Read more about this study
- Who is it for?
- Ages 16 to 89 years
- Conditions the study is for
- C.Medical Procedure; Digestive System, Disorder of Upper Gastrointestinal Tract, Tolerance
- What is being tested?
- Case Group
- How many people
- 497 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2013to May 2014
- Phase
- Observational
- 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 16 to 89 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All the patients who underwent upper gastrointestinal endoscopy in Endoscopy Room 2, Digestive Disease Center, Halla General Hospital, Jeju, Korea were enrolled consecutively during Nov. 4 2013 - May 7 2014.
Who may be able to join
- All the patients who underwent upper gastrointestinal endoscopy in Endoscopy Room, Cheju Hall General Hospital.
Who cannot join
- advanced older or younger age (> 90, or < 15 years)
- comorbidities scored greater than III of American Society of Anestheiologists Physical Status Classification System (ASA) score
- history of hypersensitivity reaction to lidocaine
- he pregnant
- therapeutic or emergency endoscopy
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Digestive Disease Center and Department of Internal Medicine, Cheju Halla General Hospital
Jeju City, Jeju Special Self-Governing Province, 690-766
About this study
Official title: Does Use of Lidocaine Spray on an Endoscope Immediately Before Insertion Improve Patient Tolerance to Endoscopy? A Single Center, Case-Control Study.
The investigators tested whether a new method which additional lidocaine spray on the tip of endoscope can increase the tolerance of examinee during endoscopy than conventional pharyngeal anesthesia alone.
Read the detailed description
All the patients underwent upper gastrointestinal endoscopy were consecutively enrolled and assigned to case group treated with additional 2 puffs of the 10% lidocaine spray on the tip of endoscope before intubation or control group with conventional pharyngeal anesthesia without further treatment. And the investigators compared their baseline characteristics, past history, sedation or not, and frequency of retching and belching were measured during the endoscopy.
- Conditions
- C.Medical Procedure; Digestive System, Disorder of Upper Gastrointestinal Tract, Tolerance
- Being tested
- Case Group
- Keywords
- Upper Gastrointestinal Endoscopy, Pharyngeal Anesthesia, Lidocaine, Belching, Retching, Tolerance
- Medical subject headings
- Eructation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case GroupDrug
Also called Beracaine Spray
Consecutively, all the participants were assigned to case group with additional 2 puffs of the 10% lidocaine spray on the tip of endoscope, same medication which was used for prior pharyngeal anesthesia, or to control group with conventional pharyngeal anesthesia without further treatment. Then we compared the primary outcome measures, such as, frequency of belching and retching of two groups.
| Study group | Role | What they receive |
|---|---|---|
| Case Group | Treated with additional 2 puffs of the 10% lidocaine spray on the tip of endoscope before intubation with conventional pharyngeal anesthesia Receives: Drug: Case Group | |
| Control Group | Treated with conventional pharyngeal anesthesia without further treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Belching and retching
Belching was defined as release of gas from the digestive tract (mainly esophagus and stomach) through the mouth and retching was defined as reverse peristaltic movement of the stomach and esophagus without vomiting.
Measured: Participants will be followed for the duration of hospital stay, expected average of 1-2 hours
Secondary outcomes (1)
Adverse events
Events suspected as Aspiration pneumonia, methemoglobinemia
Measured: Participants will be followed for the duration of hospital stay, expected average of 1-2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startNov 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for C.Medical Procedure; Digestive SystemStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 497 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cheju Halla General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Byung Hyo Cha, MD, Cheju Halla General Hospital
- Investigators
- Byung Hyo Cha, M.D., Principal investigator, Digestive Disease Center and Department of Internal Medicine, Cheju Halla General Hospital, Jeju, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02307773
- Sponsor's protocol ID
- 2013-M08
- Status last verified
- Dec 2014
- First submitted
- 1 Dec 2014
- Last updated
- 13 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gordon MJ, Mayes GR, Meyer GW. Topical lidocaine in preendoscopic medication. Gastroenterology. 1976 Oct;71(4):564-9.
PubMed 782997Isenberg G. Topical anesthesia: to use or not to use--that is the question. Gastrointest Endosc. 2001 Jan;53(1):130-3. doi: 10.1067/mge.2001.112093. No abstract available.
PubMed 11154514Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9. doi: 10.1136/bmj.2.5920.656.
PubMed 4835444Lundell LR, Dent J, Bennett JR, Blum AL, Armstrong D, Galmiche JP, Johnson F, Hongo M, Richter JE, Spechler SJ, Tytgat GN, Wallin L. Endoscopic assessment of oesophagitis: clinical and functional correlates and further validation of the Los Angeles classification. Gut. 1999 Aug;45(2):172-80. doi: 10.1136/gut.45.2.172.
PubMed 10403727Lachter J, Jacobs R, Lavy A, Weisler A, Suissa A, Enat R, Eidelman S. Topical pharyngeal anesthesia for easing endoscopy: a double-blind, randomized, placebo-controlled study. Gastrointest Endosc. 1990 Jan-Feb;36(1):19-21. doi: 10.1016/s0016-5107(90)70915-7.
PubMed 2179038Leitch DG, Wicks J, el Beshir OA, Ali SA, Chaudhury BK. Topical anesthesia with 50 mg of lidocaine spray facilitates upper gastrointestinal endoscopy. Gastrointest Endosc. 1993 May-Jun;39(3):384-7. doi: 10.1016/s0016-5107(93)70110-8.
PubMed 8514070Soma Y, Saito H, Kishibe T, Takahashi T, Tanaka H, Munakata A. Evaluation of topical pharyngeal anesthesia for upper endoscopy including factors associated with patient tolerance. Gastrointest Endosc. 2001 Jan;53(1):14-8. doi: 10.1067/mge.2001.111773.
PubMed 11154482Hedenbro JL, Ekelund M, Jansson O, Lindblom A. A randomized, double-blind, placebo-controlled study to evaluate topical anaesthesia of the pharynx in upper gastrointestinal endoscopy. Endoscopy. 1992 Aug;24(6):585-7. doi: 10.1055/s-2007-1010550.
PubMed 1396370Karim A, Ahmed S, Siddiqui R, Mattana J. Methemoglobinemia complicating topical lidocaine used during endoscopic procedures. Am J Med. 2001 Aug;111(2):150-3. doi: 10.1016/s0002-9343(01)00763-x. No abstract available.
PubMed 11498069Gunaratnam NT, Vazquez-Sequeiros E, Gostout CJ, Alexander GL. Methemoglobinemia related to topical benzocaine use: is it time to reconsider the empiric use of topical anesthesia before sedated EGD? Gastrointest Endosc. 2000 Nov;52(5):692-3. doi: 10.1067/mge.2000.110078. No abstract available.
PubMed 11060205Abdallah HY, Shah SA. Methemoglobinemia induced by topical benzocaine: a warning for the endoscopist. Endoscopy. 2002 Sep;34(9):730-4. doi: 10.1055/s-2002-33450.
PubMed 12195332
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Use of Lidocaine Spray on an Endoscope Immediately Before Insertion Improve Patient Tolerance to Endoscopy? A Single Center, Case-Control Study.
- ClinicalTrials.gov ID
- NCT02307773
- Acronym / sponsor ID
- 2013-M08
- Conditions
- C.Medical Procedure; Digestive System, Disorder of Upper Gastrointestinal Tract, Tolerance
- Keywords
- Upper Gastrointestinal Endoscopy, Pharyngeal Anesthesia, Lidocaine, Belching, Retching, Tolerance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 497 participants (actual)
- Lead sponsor
- Cheju Halla General HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 4 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.
The investigators tested whether a new method which additional lidocaine spray on the tip of endoscope can increase the tolerance of examinee during endoscopy than conventional pharyngeal anesthesia alone.
Detailed description
All the patients underwent upper gastrointestinal endoscopy were consecutively enrolled and assigned to case group treated with additional 2 puffs of the 10% lidocaine spray on the tip of endoscope before intubation or control group with conventional pharyngeal anesthesia without further treatment. And the investigators compared their baseline characteristics, past history, sedation or not, and frequency of retching and belching were measured during the endoscopy.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case Group | – | Drug: Case GroupTreated with additional 2 puffs of the 10% lidocaine spray on the tip of endoscope before intubation with conventional pharyngeal anesthesia |
| Control Group | – | –Treated with conventional pharyngeal anesthesia without further treatment. |
Who may qualify
- Ages
- 16 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All the patients who underwent upper gastrointestinal endoscopy in Endoscopy Room 2, Digestive Disease Center, Halla General Hospital, Jeju, Korea were enrolled consecutively during Nov. 4 2013 - May 7 2014.
Key inclusion criteria (1 listed)
- All the patients who underwent upper gastrointestinal endoscopy in Endoscopy Room, Cheju Hall General Hospital.
Key exclusion criteria (5 listed)
- advanced older or younger age (> 90, or < 15 years)
- comorbidities scored greater than III of American Society of Anestheiologists Physical Status Classification System (ASA) score
- history of hypersensitivity reaction to lidocaine
- he pregnant
- therapeutic or emergency endoscopy
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 |
|---|---|---|
| Case GroupAlso: Beracaine SprayConsecutively, all the participants were assigned to case group with additional 2 puffs of the 10% lidocaine spray on the tip of endoscope, same medication which was used for prior pharyngeal anesthesia, or to control group with conventional pharyngeal anesthesia without further treatment. Then we compared the primary outcome measures, such as, frequency of belching and retching of two groups. | Drug | Case Group |
Primary outcome
Frequency of Belching and retching
Time frame: Participants will be followed for the duration of hospital stay, expected average of 1-2 hours
Belching was defined as release of gas from the digestive tract (mainly esophagus and stomach) through the mouth and retching was defined as reverse peristaltic movement of the stomach and esophagus without vomiting.
1 secondary outcome
Adverse events
Time frame: Participants will be followed for the duration of hospital stay, expected average of 1-2 hours
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 13 Jan 2015.
- Background: PubMed 782997Gordon MJ, Mayes GR, Meyer GW. Topical lidocaine in preendoscopic medication. Gastroenterology. 1976 Oct;71(4):564-9.
- Background: PubMed 11154514Isenberg G. Topical anesthesia: to use or not to use--that is the question. Gastrointest Endosc. 2001 Jan;53(1):130-3. doi: 10.1067/mge.2001.112093. No abstract available.
- Background: PubMed 4835444Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9. doi: 10.1136/bmj.2.5920.656.
- Background: PubMed 10403727Lundell LR, Dent J, Bennett JR, Blum AL, Armstrong D, Galmiche JP, Johnson F, Hongo M, Richter JE, Spechler SJ, Tytgat GN, Wallin L. Endoscopic assessment of oesophagitis: clinical and functional correlates and further validation of the Los Angeles classification. Gut. 1999 Aug;45(2):172-80. doi: 10.1136/gut.45.2.172.
- Background: PubMed 2179038Lachter J, Jacobs R, Lavy A, Weisler A, Suissa A, Enat R, Eidelman S. Topical pharyngeal anesthesia for easing endoscopy: a double-blind, randomized, placebo-controlled study. Gastrointest Endosc. 1990 Jan-Feb;36(1):19-21. doi: 10.1016/s0016-5107(90)70915-7.
- Background: PubMed 8514070Leitch DG, Wicks J, el Beshir OA, Ali SA, Chaudhury BK. Topical anesthesia with 50 mg of lidocaine spray facilitates upper gastrointestinal endoscopy. Gastrointest Endosc. 1993 May-Jun;39(3):384-7. doi: 10.1016/s0016-5107(93)70110-8.
- Background: PubMed 11154482Soma Y, Saito H, Kishibe T, Takahashi T, Tanaka H, Munakata A. Evaluation of topical pharyngeal anesthesia for upper endoscopy including factors associated with patient tolerance. Gastrointest Endosc. 2001 Jan;53(1):14-8. doi: 10.1067/mge.2001.111773.
- Background: PubMed 1396370Hedenbro JL, Ekelund M, Jansson O, Lindblom A. A randomized, double-blind, placebo-controlled study to evaluate topical anaesthesia of the pharynx in upper gastrointestinal endoscopy. Endoscopy. 1992 Aug;24(6):585-7. doi: 10.1055/s-2007-1010550.
- Background: PubMed 11498069Karim A, Ahmed S, Siddiqui R, Mattana J. Methemoglobinemia complicating topical lidocaine used during endoscopic procedures. Am J Med. 2001 Aug;111(2):150-3. doi: 10.1016/s0002-9343(01)00763-x. No abstract available.
- Background: PubMed 11060205Gunaratnam NT, Vazquez-Sequeiros E, Gostout CJ, Alexander GL. Methemoglobinemia related to topical benzocaine use: is it time to reconsider the empiric use of topical anesthesia before sedated EGD? Gastrointest Endosc. 2000 Nov;52(5):692-3. doi: 10.1067/mge.2000.110078. No abstract available.
- Background: PubMed 12195332Abdallah HY, Shah SA. Methemoglobinemia induced by topical benzocaine: a warning for the endoscopist. Endoscopy. 2002 Sep;34(9):730-4. doi: 10.1055/s-2002-33450.
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.
Byung Hyo Cha, M.D. principal investigator
Digestive Disease Center and Department of Internal Medicine, Cheju Halla General Hospital, Jeju, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of C.Medical Procedure; Digestive System and Disorder of Upper Gastrointestinal Tract, run by Cheju Halla General Hospital at 1 site in South Korea.
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 1 inclusion and 5 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 13 Jan 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 South Korea. 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.
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?
Frequency of Belching and retching (time frame: Participants will be followed for the duration of hospital stay, expected average of 1-2 hours). 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 NCT02307773, which also lists 11 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 13 Jan 2015.