Comparison of Topical and Nebulized Anesthesia in Patients Undergoing Esophago-Gastro-Duodenoscopy

Phase 4

• Conditions: Anesthesia of Mucous Membrane
• Interventions: Drug: Lidocaine Spray; Drug: Nebulized Lidocaine

• Registration Number: NCT02317770
• Lead Sponsor: Mahidol University

Brief Summary

This study compares the effect of nebulized lidocaine and lidocaine spray in patients undergoing esophago-gastro-duodenoscopy. The investigators evaluate the success rate of the procedure between two methods.

Detailed Description

This is a randomized-controlled trial in the patients undergoing esophago-gastro-duodenoscopy. The patients are randomized by computer into two arms: nebulized lidocaine and lidocaine spray. Both drugs are applied 15-20 minutes prior the prior the procedure. Only one endoscopist participate in this study. After the procedure finishes, the investigators evaluate the outcome and satisfaction of patients and endoscopist.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-12-11
• Study First Submitted QC: 2014-12-15
• Study First Posted: 2014-12-16
• Status Verified: 2016-03
• Primary Completion: 2016-03
• Last Update Submitted: 2016-03-15
• Last Update Posted: 2016-03-16
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• elective case for esophago-gastro-duodenoscopy with ASA classification 1-2
• Both genders
• Age between 18-65 years

Exclusion Criteria

• History of smoking
• Upper respiratory tract infection
• Asthma
• Heart disease
• Allergy to local anesthetic drugs

Withdrawal or termination criteria

• Patient refusal
• Patient develops lidocaine allergy
• Bronchospasm
• Sign of Local Anesthetic Toxicity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine Spray	Lidocaine Spray	20 puffs of 10% Lidocaine spray
Nebulized Lidocaine	Nebulized Lidocaine	2.5 mL of 10% Lidocaine

Primary Outcome Measures

Name	Time	Method
Comparison of Topical and Nebulized Anesthesia	90 min	Both nurse anesthetist and endoscopist evaluate difficulty during the procedure and demand for additional sedative drugs using numeric scale

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction	90 min	Satisfaction is evaluated using Numeric Rating Scale (0-10)
Operator Satisfaction	30 min	Satisfaction is evaluated using Numeric Rating Scale (0-10)

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital; 🇹🇭 Bangkoknoi, Bangkok, Thailand