LIDOCAINE SPRAY VS VISCOUS LIDOCAINE SOLUTION PLUS LIDOCAINE SPRAY IN PATIENTS UNDERGOING NON-SEDATED ESOPHAGOGASTRODUODENOSCOPY: A RANDOMIZED CONTROLLED TRIAL

Study Overview
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Brief Summary
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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).

Detailed Description
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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

Official Title
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LIDOCAINE SPRAY VERSUS VISCOUS LIDOCAINE SOLUTION PLUS LIDOCAINE SPRAY IN PATIENTS UNDERGOING NON-SEDATED ESOPHAGOGASTRODUODENOSCOPY: A RANDOMIZED CONTROLLED TRIAL

Conditions
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Pain, Satisfaction, Patient, Satisfaction Endoscopist

Intervention / Treatment
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* Drug: Lidocaine Spray
* Drug: Lidocaine Viscous+Lidocane spray


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: lidocaine spray alone<br>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<br>* 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<br>|
| Active Comparator: receive lidocaine spray + lidocaine viscous solution<br>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<br>* 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<br>|

What is the study measuring?
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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 |