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

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

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2016-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anesthesia of Mucous Membrane

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Lidocaine Spray

20 puffs of 10% Lidocaine spray

Group Type ACTIVE_COMPARATOR

Lidocaine Spray

Intervention Type DRUG

5 puffs of 10% Lidocaine spray is administered every 5 minutes for 4 times. Then the patient is undergone procedure 5 minutes later.

Nebulized Lidocaine

2.5 mL of 10% Lidocaine

Group Type ACTIVE_COMPARATOR

Nebulized Lidocaine

Intervention Type DRUG

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.

Interventions

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Lidocaine Spray

5 puffs of 10% Lidocaine spray is administered every 5 minutes for 4 times. Then the patient is undergone procedure 5 minutes later.

Intervention Type DRUG

Nebulized Lidocaine

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.

Intervention Type DRUG

Other Intervention Names

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Xylocaine Spray Nebulized Xylocaine

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No