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

NCT06185933 | Enrolling By Invitation DMC

• 1 other identifier: NF01
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Pain; Satisfaction, Patient

Keywords

lidocaine spray; lidocaine solution; non-sedating EGD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• patient tolerance

  immediately after finished precedure

• endoscopist satisfaction

  immediately after finished precedure

• patient satisfaction

  30 minute after finished precedure

Study Arms (2)

lidocaine spray alone

ACTIVE COMPARATOR

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

receive lidocaine spray + lidocaine viscous solution

ACTIVE COMPARATOR

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

Interventions

Lidocaine Spray DRUG

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

Also known as: liocaine spray

lidocaine spray alone

Lidocaine Viscous+Lidocane spray DRUG

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

Also known as: Lidocaine Viscous, Lidocane spray

receive lidocaine spray + lidocaine viscous solution

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sawanpracharak hospital: lead

Study Sites (1)

Sawanpracharak hospital

Nakhon Sawan, Nakhonsawan, 60000, Thailand

Location

MeSH Terms

Conditions

Pain; Patient Satisfaction

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Natee Faknak

  Saawanpracharak hospital Thailand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical doctor at Department of medicine Sawanpracharak hospital

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: December 29, 2023
• Study Start: February 4, 2024
• Primary Completion: July 4, 2024
• Study Completion: October 30, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)