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

N/AEnrolling By InvitationNCT06185933

Sawanpracharak hospital250 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

250

Conditions

Pain Satisfaction, Patient

Interventions

Lidocaine SprayDRUG

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

Lidocaine Viscous+Lidocane sprayDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sawanpracharak hospital

Nakhon Sawan, Nakhonsawan, Thailand

Outcomes

Primary Outcomes

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

Time frame: 30 minute after finished precedure

Secondary Outcomes

patient tolerance

1 = exceptional; 2 = well; 3 = fair; 4 = poor answer by endoscopist

Time frame: immediately after finished precedure

endoscopist satisfaction

1 = very satisfied; 2 = satisfied; 3 = neutral; and 4 = dissatisfied

Time frame: immediately after finished precedure

patient satisfaction

1 = very satisfied; 2 = satisfied; 3 = neutral; and 4 = dissatisfied

Time frame: 30 minute after finished precedure

Data from ClinicalTrials.gov

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