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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02317770

Enrollment

110

Registered

2014-12-16

Start date

2013-11-30

Completion date

2016-04-30

Last updated

2016-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia of Mucous Membrane

Keywords

lidocaine, esophago-gastro-duodenoscopy

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.

Interventions

DRUGLidocaine Spray

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

DRUGNebulized 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

Thailand

Contacts

Primary ContactPapiroon Noitasaeng, RN

papiroonnoi@gmail.com66(81)4930935

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026