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

Mahidol University

Status and phase: Unknown; Phase 4

Conditions: Anesthesia of Mucous Membrane

Treatments: Drug: Lidocaine Spray; Drug: Nebulized Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02317770

SI534/2013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

110 participants in 2 patient groups

Lidocaine Spray

Active Comparator group

Description:

20 puffs of 10% Lidocaine spray

Treatment:

Drug: Lidocaine Spray

Nebulized Lidocaine

Active Comparator group

Description:

2.5 mL of 10% Lidocaine

Treatment:

Drug: Nebulized Lidocaine