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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1-minute group | Placebo Comparator | 6 puff of lidocaine was delivered 1 minute before the initiation of EGD insertion |
|
| 3-minute group | Active Comparator | 6 puff of lidocaine was delivered 3 minutes before the initiation of EGD insertion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | Lidocaine spray in both group with same puff number, but the timing before EGD insertion is different |
|
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate change | The increase level of heart rate between baseline and during the pharynx insertion of EGD | 1 day |
| Blood pressure change | The increase level of systolic blood pressure between baseline and during the pharynx insertion of EGD | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hsueh-Chien Chiang, M.D. | Contact | 062353535 | scion456scion@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hsueh-Chien Chiang | Recruiting | Tainan | Other (Non U.s.) | 704 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25480102 | Result | 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. | |
| 22985638 | Result | ASGE 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. |
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IPD will be shared after publication
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| ID | Term |
|---|---|
| D013610 | Tachycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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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
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Sealed and ordered envelope will be opened by assistant and the allocation was written on it. After then, lidocaine spray will be administered. The operator will be informed to prepare 30 seconds before the EGD initiation.
| 15692924 | Result | Lazzaroni M, Bianchi Porro G. Preparation, premedication, and surveillance. Endoscopy. 2005 Feb;37(2):101-9. doi: 10.1055/s-2004-826149. |
| 8514070 | Result | Leitch 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. |
| 16650534 | Result | Evans 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. |
| 24682602 | Result | Hwang 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. |
| 34644419 | Result | 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. |
| 40166898 | Derived | Chiang 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. |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |