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At recent, the number of patients who underwent sedated esophagogastroduodenoscopy has been on the increase. For such patients, whether topical pharyngeal anesthesia is needed remains to be controversial. European Society of Gastrointestinal Endoscopy, European Society of Gastroenterology and Endoscopy Nurses and Associates, and the European Society of Anaesthesiology Guideline for non-anesthesiologist administration of propofol for GI endoscopy have not made any recommendation, because the role of pharyngeal anesthesia during propofol sedation for upper digestive endoscopy has not been assessed. Our study aimed at investigating whether topical lidocaine pharyngeal anesthesia could benefit patients who underwent esophagogastroduodenoscopy under propofol sedation.
Propofol sedation has been widely applied in endoscopic examinations. For such patients, whether lidocaine topical pharyngeal anesthesia should be administrated is still in doubt. Considering the fact that lidocaine anesthesia may cause airway narrowing and anaphylaxis, it is important to clarify the role of lidocaine topical pharyngeal anesthesia in esophagogastroduodenoscopy under propofol sedation. Our study could test whether lidocaine topical pharyngeal anesthesia should be performed in sedated esophagogastroduodenoscopy in a randomized controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Topical lidocaine pharyngeal anesthesia was performed. |
|
| Control group | No Intervention | No topical lidocaine pharyngeal anesthesia was performed. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical lidocaine pharyngeal anesthesia | Procedure | Topical pharyngeal anesthesia by lidocaine was administrated 4-5 min before propofol sedation in patients who underwent esophagogastroduodenoscopy. |
| Measure | Description | Time Frame |
|---|---|---|
| Immediate throat pain score | Immediate throat discomfort will be recorded, and pain score (0 no pain - 10 most painful) will be given by the patients. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Throat discomfort 1 day after the procedure | All the patients will be followed up by telephone 1 day after the endoscopic examination. Throat Discomfort will be recorded. | 1 day |
| Adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaotian Sun, M.D., Ph.D. | Contact | +86-010-66947473 | xiaotian-sun@hotmail.com | |
| Yang Xu, M.D., Ph.D. | Contact | +86-010-66947473 | yanuoda531@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yang Liu, M.D., Ph.D. | Department of gastroenterology,Affiliated Hospital to Academy of Military Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital to Academy of Military Medical Sciences | Recruiting | Beijing | 100071 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22000794 | Background | Heuss LT, Hanhart A, Dell-Kuster S, Zdrnja K, Ortmann M, Beglinger C, Bucher HC, Degen L. Propofol sedation alone or in combination with pharyngeal lidocaine anesthesia for routine upper GI endoscopy: a randomized, double-blind, placebo-controlled, non-inferiority trial. Gastrointest Endosc. 2011 Dec;74(6):1207-14. doi: 10.1016/j.gie.2011.07.072. Epub 2011 Oct 13. | |
| 21072716 |
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All the adverse events during the sedated endoscopic examination will be recorded.
| 1 day |
| Satisfaction score | Patients will give a satisfaction score of 0 (unsatisfied) -10 (very satisfied) based on their own experience. | 1 day |
| Dumonceau JM, Riphaus A, Aparicio JR, Beilenhoff U, Knape JT, Ortmann M, Paspatis G, Ponsioen CY, Racz I, Schreiber F, Vilmann P, Wehrmann T, Wientjes C, Walder B; NAAP Task Force Members. European Society of Gastrointestinal Endoscopy, European Society of Gastroenterology and Endoscopy Nurses and Associates, and the European Society of Anaesthesiology Guideline: Non-anesthesiologist administration of propofol for GI endoscopy. Endoscopy. 2010 Nov;42(11):960-74. doi: 10.1055/s-0030-1255728. Epub 2010 Nov 11. |
| 29703990 | Derived | Sun X, Xu Y, Zhang X, Li A, Zhang H, Yang T, Liu Y. Topical pharyngeal anesthesia provides no additional benefit to propofol sedation for esophagogastroduodenoscopy: a randomized controlled double-blinded clinical trial. Sci Rep. 2018 Apr 27;8(1):6682. doi: 10.1038/s41598-018-25164-7. |