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

Study Overview
=================
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.

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

Conditions
-----------------
Anesthesia of Mucous Membrane

Intervention / Treatment
-----------------
* Drug: Lidocaine Spray
* Drug: Nebulized Lidocaine


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lidocaine Spray<br>20 puffs of 10% Lidocaine spray | Drug: Lidocaine Spray<br>* 5 puffs of 10% Lidocaine spray is administered every 5 minutes for 4 times. Then the patient is undergone procedure 5 minutes later.<br>* Other names: Xylocaine Spray;|
| Active Comparator: Nebulized Lidocaine<br>2.5 mL of 10% Lidocaine | Drug: Nebulized Lidocaine<br>* The patient receives 2.5 mL of 10% lidocaine is used by nebulizer under oxygen flow 6-7 LPM for 15 minutes prior the procedure.<br>* Other names: Nebulized Xylocaine;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Topical and Nebulized Anesthesia | Both nurse anesthetist and endoscopist evaluate difficulty during the procedure and demand for additional sedative drugs using numeric scale | 90 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction | Satisfaction is evaluated using Numeric Rating Scale (0-10) | 90 min | 
| Operator Satisfaction | Satisfaction is evaluated using Numeric Rating Scale (0-10) | 30 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lidocaine, esophago-gastro-duodenoscopy