Lidocaine Spray vs Viscous Lidocaine Solution Plus Lidocaine Spray in Patients Undergoing Non-Sedated EGD

Lidocaine Spray vs Viscous Lidocaine Solution Plus Lidocaine Spray in Patients Undergoing Non-Sedated Esophagogastroduodenoscopy: A Randomized Controlled Trial

This study aimed to compare the efficacy of lidocaine spray (S) alone versus lidocaine spray combined with lidocaine viscous solution (S+V) in facilitating pharyngeal observation during Non-sedating upper gastrointestinal endoscopy (UGE).

Study Overview

• Status: Enrolling by invitation
• Conditions: Pain; Satisfaction, Patient
• Intervention / Treatment: Drug: Lidocaine Spray; Drug: Lidocaine Viscous+Lidocane spray

Detailed Description

A randomized controlled trial was conducted between July and October 2023 at Sawanpracharak hospital, Thailand. Of 250 patients undergoing UGE, 125 were randomly assigned to group S (lidocaine spray alone) and 125 to group S+V (lidocaine spray plus lidocaine viscous solution). The total dose of lidocaine did not exceed 5 mg/kg in both groups

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Nakhonsawan
    • Nakhon Sawan, Nakhonsawan, Thailand, 60000
      • Sawanpracharak Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients scheduled for upper gastrointestinal endoscopy:
• Patients who are robust, without chronic illnesses, or with controlled chronic conditions that do not adversely affect the function of any organ (American Society of Anesthesiologists (ASA) physical status classification I-II).

Exclusion Criteria:

• Has a history of receiving painkillers or sleeping pills within 24 hours before the endoscopy.
• Has a history of post-endoscopy nausea and vomiting.
• Patients who have undergone upper gastrointestinal endoscopy previously.
• Has chronic conditions such as epilepsy, vertigo, or mental health disorders.
• Has a history of allergy to anesthesia used in the study.
• Pregnant or currently breastfeeding.
• Refuses to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: lidocaine spray alone; patient in this arm will receive lidocaine spray five puffs of 10 % lidocaine spray (Xylocaine 10 % Spray, Astra Zeneca) (1 puff = 10 mg of lidocaine) 5 minutes before the start of the procedure	Drug: Lidocaine Spray; Pharyngeal anesthesia using a topical lidocaine spray was administered in the preprocedure room, in the absence of the endoscopist or the research assistant. 5 minute before the UGE without any sedation; Other Names: liocaine spray
Active Comparator: receive lidocaine spray + lidocaine viscous solution; patient in this arm will receive lidocaine spray + lidocaine viscous solution five puffs of 10 % lidocaine spray (Xylocaine 10 % Spray, Astra Zeneca) (1 puff = 10 mg of lidocaine) Plus 5 mL of 2 % viscous lidocaine solution (20 mg/mL) (Xylocaine 2 %, Astra Zeneca, London, UK)	Drug: Lidocaine Viscous+Lidocane spray; Pharyngeal anesthesia using topical viscous lidocaine solution + lidocaine spray were administered in the preprocedure room, in the absence of the endoscopist or the research assistant. 5 minute before the UGE without any sedation; Other Names: Lidocaine Viscous; Lidocane spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
procedural pain, measured using the visual analog scale (VAS).	The procedural pain was evaluated using a visual analog scale (VAS, 0-10) with 0 being none and 10 being the most painfull	30 minute after finished precedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient tolerance	1 = exceptional; 2 = well; 3 = fair; 4 = poor answer by endoscopist	immediately after finished precedure
endoscopist satisfaction	1 = very satisfied; 2 = satisfied; 3 = neutral; and 4 = dissatisfied	immediately after finished precedure
patient satisfaction	1 = very satisfied; 2 = satisfied; 3 = neutral; and 4 = dissatisfied	30 minute after finished precedure

Collaborators and Investigators

• Sponsor: Sawanpracharak hospital
• Investigators: Principal Investigator: Natee Faknak, Saawanpracharak hospital Thailand

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2024
• Primary Completion (Estimated): July 4, 2024
• Study Completion (Estimated): October 30, 2024

Study Registration Dates

• First Submitted: December 15, 2023
• First Submitted That Met QC Criteria: December 15, 2023
• First Posted (Actual): December 29, 2023

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: lidocaine spray; lidocaine solution; non-sedating EGD
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: NF01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No