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

Anesthesia of Mucous Membrane Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02317770
• Other study ID #: SI534/2013
• Status: Recruiting
• Phase: Phase 4
• First received: December 11, 2014
• Last updated: March 15, 2016
• Start date: November 2013
• Est. completion date: April 2016

Study information

• Verified date: March 2016
• Source: Mahidol University
• Contact: Papiroon Noitasaeng, RN
• Phone: 66(81)4930935
• Email: papiroonnoi[@]gmail.com
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia of Mucous Membrane

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (2)

Dhir V, Swaroop VS, Vazifdar KF, Wagle SD. Topical pharyngeal anesthesia without intravenous sedation during upper gastrointestinal endoscopy. Indian J Gastroenterol. 1997 Jan;16(1):10-1. — View Citation

Korttila K, Tarkkanen J, Tarkkanen L. Comparison of laryngotracheal and ultrasonic nebulizer administration of lidocaine in local anaesthesia for bronchoscopy. Acta Anaesthesiol Scand. 1981 Apr;25(2):161-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Patient Satisfaction	Satisfaction is evaluated using Numeric Rating Scale (0-10)	90 min	No
Secondary	Operator Satisfaction	Satisfaction is evaluated using Numeric Rating Scale (0-10)	30 min	No