Blood PressureNCT06497296
The Optimal Timing of the Initiation of Esophagogastroduodenoscopy After Oral Lidocaine Spray
A study testing Lidocaine in people with Blood Pressure and Tachycardia, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
Esophagogastroduodenoscopy (EGD) is the main examination in the upper gastrointestinal field. Aspiration pneumonia may happen if choking occurs during the EGD insertion, and the exam quality and efficacy may be affected if gag reflex occurs. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Blood Pressure, Tachycardia
- What is being tested?
- Lidocaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2023to 31 Dec 2024
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible participants included patients aged ≥ 20 years who scheduled EGD from OPD for dyspepsia, peptic ulcer disease, GERD, subepithelial lesion evaluation, and diarrhea
Who cannot join
- GI bleeding
- endoscopic submucosal dissection due to prolonged scheduled procedure time
- patients from emergency department or ward
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Hsueh-Chien Chiang
Tainan, Other (Non U.s.), 704
Hsueh-Chien Chiang, 2353535, scion456scion@gmail.com
About this study
Esophagogastroduodenoscopy (EGD) is the main examination in the upper gastrointestinal field. Aspiration pneumonia may happen if choking occurs during the EGD insertion, and the exam quality and efficacy may be affected if gag reflex occurs. The endoscopist may terminate the exam to avoid complications if the patient could not obey the orders. To reach the high quality of EGD examination and to avoid possible complications, the patient's comfort and compliance during the EGD examination are important. Sedation using propofol can improve the patient's comfort and compliance. However, in patients unsuitable for systemic anesthesia, local lidocaine spray at pharynx is performed instead. Until now, there is no standardization of the waiting time between lidocaine spray and the initiation of EGD. This study aimed to investigate the optimal timing of the initiation of esophagogastroduodenoscopy after lidocaine spray.
Read the detailed description
This study compares the 1-minute waiting time and 3-minute waiting time between the lidocaine spray and the EGD initiation. During the topical anesthesia stage, investigators give local spray with 6 puff on pharynx at the 0 minute in both groups. After the waiting time, EGD is inserted.
The baseline heart rate and blood pressure were recorded before EGD and during the EGD passing through pharynx respectively. After the whole procedure, enrolled patients will fill in the EGD quality questionnaire.
Through this study, investigators can figure out whether 1 minute or 3 minutes may be the optimal waiting time after lidocaine spray.
- Conditions
- Blood Pressure, Tachycardia
- Being tested
- Lidocaine
- Medical subject headings
- Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Lidocaine spray in both group with same puff number, but the timing before EGD insertion is different
| Study group | Role | What they receive |
|---|---|---|
| 1-minute group | Placebo comparator | 6 puff of lidocaine was delivered 1 minute before the initiation of EGD insertion Receives: Drug: Lidocaine |
| 3-minute group | Active comparator | 6 puff of lidocaine was delivered 3 minutes before the initiation of EGD insertion Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate change
The increase level of heart rate between baseline and during the pharynx insertion of EGD
Measured: 1 day
Blood pressure change
The increase level of systolic blood pressure between baseline and during the pharynx insertion of EGD
Measured: 1 day
Secondary outcomes (1)
EGD comfort quality questionnaire score
comfort quality questionnaire will be written by an assistant and the patient after the EGD procedure. The score includes pain feeling (1-5 points), nausea sensation (1-5 points), abdominal fullness (1-5 points). A higher score indicates more discomfort.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start1 Jan 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Both group accepted 6 puff of lidocaine spray. EGD will be inserted one minute after the lidocaine spray in 1-minute group and 3 minutes waiting in 3-minute group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsueh-Chien Chiang, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497296
- Sponsor's protocol ID
- B-ER-111-218
- Status last verified
- Jul 2024
- First submitted
- 2 Jul 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared after publication
Publications
Rizk MK, Sawhney MS, Cohen J, Pike IM, Adler DG, Dominitz JA, Lieb JG 2nd, Lieberman DA, Park WG, Shaheen NJ, Wani S. Quality indicators common to all GI endoscopic procedures. Gastrointest Endosc. 2015 Jan;81(1):3-16. doi: 10.1016/j.gie.2014.07.055. Epub 2014 Dec 2. No abstract available.
PubMed 25480102ASGE Standards of Practice Committee; Ben-Menachem T, Decker GA, Early DS, Evans J, Fanelli RD, Fisher DA, Fisher L, Fukami N, Hwang JH, Ikenberry SO, Jain R, Jue TL, Khan KM, Krinsky ML, Malpas PM, Maple JT, Sharaf RN, Dominitz JA, Cash BD. Adverse events of upper GI endoscopy. Gastrointest Endosc. 2012 Oct;76(4):707-18. doi: 10.1016/j.gie.2012.03.252. No abstract available.
PubMed 22985638Lazzaroni M, Bianchi Porro G. Preparation, premedication, and surveillance. Endoscopy. 2005 Feb;37(2):101-9. doi: 10.1055/s-2004-826149.
PubMed 15692924Leitch 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 8514070Evans LT, Saberi S, Kim HM, Elta GH, Schoenfeld P. Pharyngeal anesthesia during sedated EGDs: is "the spray" beneficial? A meta-analysis and systematic review. Gastrointest Endosc. 2006 May;63(6):761-6. doi: 10.1016/j.gie.2005.11.059.
PubMed 16650534Hwang SH, Park CS, Kim BG, Cho JH, Kang JM. Topical anesthetic preparations for rigid and flexible endoscopy: a meta-analysis. Eur Arch Otorhinolaryngol. 2015 Feb;272(2):263-70. doi: 10.1007/s00405-014-3012-8. Epub 2014 Mar 29.
PubMed 24682602Martin-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 34644419Chiang HC, Chiang CM, Chang WL, Lin MY. Clinical Trial: The Optimal Timing of the Endoscope Insertion After Oral Lidocaine Spray. A Randomized Controlled Trial. J Gastroenterol Hepatol. 2025 Jun;40(6):1428-1434. doi: 10.1111/jgh.16958. Epub 2025 Apr 1.
PubMed 40166898
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimal Timing of the Initiation of Esophagogastroduodenoscopy After Oral Lidocaine Spray
- ClinicalTrials.gov ID
- NCT06497296
- Acronym / sponsor ID
- B-ER-111-218
- Conditions
- Blood Pressure, Tachycardia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 11 Jul 2024 (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.
Esophagogastroduodenoscopy (EGD) is the main examination in the upper gastrointestinal field. Aspiration pneumonia may happen if choking occurs during the EGD insertion, and the exam quality and efficacy may be affected if gag reflex occurs. The endoscopist may terminate the exam to avoid complications if the patient could not obey the orders. To reach the high quality of EGD examination and to avoid possible complications, the patient's comfort and compliance during the EGD examination are important. Sedation using propofol can improve the patient's comfort and compliance. However, in patients unsuitable for systemic anesthesia, local lidocaine spray at pharynx is performed instead. Until now, there is no standardization of the waiting time between lidocaine spray and the initiation of EGD. This study aimed to investigate the optimal timing of the initiation of esophagogastroduodenoscopy after lidocaine spray.
Detailed description
This study compares the 1-minute waiting time and 3-minute waiting time between the lidocaine spray and the EGD initiation. During the topical anesthesia stage, investigators give local spray with 6 puff on pharynx at the 0 minute in both groups. After the waiting time, EGD is inserted.
The baseline heart rate and blood pressure were recorded before EGD and during the EGD passing through pharynx respectively. After the whole procedure, enrolled patients will fill in the EGD quality questionnaire.
Through this study, investigators can figure out whether 1 minute or 3 minutes may be the optimal waiting time after lidocaine spray.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Both group accepted 6 puff of lidocaine spray. EGD will be inserted one minute after the lidocaine spray in 1-minute group and 3 minutes waiting in 3-minute group
| Arm | Type | Receives |
|---|---|---|
| 1-minute group | Placebo comparator | Drug: Lidocaine6 puff of lidocaine was delivered 1 minute before the initiation of EGD insertion |
| 3-minute group | Active comparator | Drug: Lidocaine6 puff of lidocaine was delivered 3 minutes before the initiation of EGD insertion |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible participants included patients aged ≥ 20 years who scheduled EGD from OPD for dyspepsia, peptic ulcer disease, GERD, subepithelial lesion evaluation, and diarrhea
Key exclusion criteria (3 listed)
- GI bleeding
- endoscopic submucosal dissection due to prolonged scheduled procedure time
- patients from emergency department or ward
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 |
|---|---|---|
| LidocaineLidocaine spray in both group with same puff number, but the timing before EGD insertion is different | Drug | 1-minute group, 3-minute group |
Primary outcome
Heart rate change
Time frame: 1 day
The increase level of heart rate between baseline and during the pharynx insertion of EGD
Blood pressure change
Time frame: 1 day
The increase level of systolic blood pressure between baseline and during the pharynx insertion of EGD
1 secondary outcome
EGD comfort quality questionnaire score
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Results publication: PubMed 25480102Rizk MK, Sawhney MS, Cohen J, Pike IM, Adler DG, Dominitz JA, Lieb JG 2nd, Lieberman DA, Park WG, Shaheen NJ, Wani S. Quality indicators common to all GI endoscopic procedures. Gastrointest Endosc. 2015 Jan;81(1):3-16. doi: 10.1016/j.gie.2014.07.055. Epub 2014 Dec 2. No abstract available.
- Results publication: PubMed 22985638ASGE Standards of Practice Committee; Ben-Menachem T, Decker GA, Early DS, Evans J, Fanelli RD, Fisher DA, Fisher L, Fukami N, Hwang JH, Ikenberry SO, Jain R, Jue TL, Khan KM, Krinsky ML, Malpas PM, Maple JT, Sharaf RN, Dominitz JA, Cash BD. Adverse events of upper GI endoscopy. Gastrointest Endosc. 2012 Oct;76(4):707-18. doi: 10.1016/j.gie.2012.03.252. No abstract available.
- Results publication: PubMed 15692924Lazzaroni M, Bianchi Porro G. Preparation, premedication, and surveillance. Endoscopy. 2005 Feb;37(2):101-9. doi: 10.1055/s-2004-826149.
- Results publication: 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.
- Results publication: PubMed 16650534Evans LT, Saberi S, Kim HM, Elta GH, Schoenfeld P. Pharyngeal anesthesia during sedated EGDs: is "the spray" beneficial? A meta-analysis and systematic review. Gastrointest Endosc. 2006 May;63(6):761-6. doi: 10.1016/j.gie.2005.11.059.
- Results publication: PubMed 24682602Hwang SH, Park CS, Kim BG, Cho JH, Kang JM. Topical anesthetic preparations for rigid and flexible endoscopy: a meta-analysis. Eur Arch Otorhinolaryngol. 2015 Feb;272(2):263-70. doi: 10.1007/s00405-014-3012-8. Epub 2014 Mar 29.
- Results publication: 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.
- Derived from this study: PubMed 40166898Chiang HC, Chiang CM, Chang WL, Lin MY. Clinical Trial: The Optimal Timing of the Endoscope Insertion After Oral Lidocaine Spray. A Randomized Controlled Trial. J Gastroenterol Hepatol. 2025 Jun;40(6):1428-1434. doi: 10.1111/jgh.16958. Epub 2025 Apr 1.
- Individual participant dataSharing planned: Yes. IPD will be shared after publication
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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.
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 Blood Pressure and Tachycardia, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 3 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 11 Jul 2024. 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 Taiwan. 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 Hsueh-Chien Chiang, M.D. (062353535, scion456scion@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate change (time frame: 1 day). The study lists 2 primary outcomes in all. 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 NCT06497296, which also lists 8 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 11 Jul 2024.