Topical Pharyngeal Anesthesia in Sedated Esophagogastroduodenoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-20

Study Completion Date

2017-05-31

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.

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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.

Conditions

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Esophagogastroduodenoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Experimental group

Topical lidocaine pharyngeal anesthesia was performed.

Group Type EXPERIMENTAL

Topical lidocaine pharyngeal anesthesia

Intervention Type PROCEDURE

Topical pharyngeal anesthesia by lidocaine was administrated 4-5 min before propofol sedation in patients who underwent esophagogastroduodenoscopy.

Control group

No topical lidocaine pharyngeal anesthesia was performed.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Topical lidocaine pharyngeal anesthesia

Topical pharyngeal anesthesia by lidocaine was administrated 4-5 min before propofol sedation in patients who underwent esophagogastroduodenoscopy.

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes