Topical Pharyngeal Anesthesia in Sedated Esophagogastroduodenoscopy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Application of Topical Pharyngeal Anesthesia in the Esophagogastroduodenoscopy Under Sedation

Conditions
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Esophagogastroduodenoscopy

Intervention / Treatment
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* Procedure: Topical lidocaine pharyngeal anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥18 Years Patients who have indications for esophagogastroduodenoscopy American Society of Anesthesiology risk class 1, 2 or 3 Exclusion Criteria: Patients <18 years Patients with thrombocytopenia (platelet count < 50,000/microL) or elevated International Normalized Ratio (INR > 1.5) Hemodynamic instability Pregnancy and lactation Patients who are unable or unwilling to give an informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Topical lidocaine pharyngeal anesthesia was performed. | Procedure: Topical lidocaine pharyngeal anesthesia<br>* Topical pharyngeal anesthesia by lidocaine was administrated 4-5 min before propofol sedation in patients who underwent esophagogastroduodenoscopy.<br>|
| No Intervention: Control group<br>No topical lidocaine pharyngeal anesthesia was performed. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |