Topical Pharyngeal Anesthesia in Sedated Esophagogastroduodenoscopy

Not Applicable

• Conditions: Esophagogastroduodenoscopy
• Interventions: Procedure: Topical lidocaine pharyngeal anesthesia

• Registration Number: NCT03070379
• Lead Sponsor: Affiliated Hospital to Academy of Military Medical Sciences

Brief Summary

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

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.

Study Timeline

• Status Verified: 2017-02
• Study Start: 2017-02-20
• Study First Submitted: 2017-02-23
• Study First Submitted QC: 2017-03-02
• Last Update Submitted: 2017-03-02
• Study First Posted: 2017-03-03
• Last Update Posted: 2017-03-03
• Primary Completion: 2017-04
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Topical lidocaine pharyngeal anesthesia	Topical lidocaine pharyngeal anesthesia was performed.

Primary Outcome Measures

Name	Time	Method
Immediate throat pain score	1 day	Immediate throat discomfort will be recorded, and pain score (0 no pain - 10 most painful) will be given by the patients.

Secondary Outcome Measures

Name	Time	Method
Throat discomfort 1 day after the procedure	1 day	All the patients will be followed up by telephone 1 day after the endoscopic examination. Throat Discomfort will be recorded.
Adverse events	1 day	All the adverse events during the sedated endoscopic examination will be recorded.
Satisfaction score	1 day	Patients will give a satisfaction score of 0 (unsatisfied) -10 (very satisfied) based on their own experience.

Trial Locations

Locations (1)

Affiliated Hospital to Academy of Military Medical Sciences; 🇨🇳 Beijing, China