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

Not Applicable

• Conditions: Pain; Satisfaction, Patient
• Interventions: Drug: Lidocaine Spray; Drug: Lidocaine Viscous+Lidocane spray

• Registration Number: NCT06185933
• Lead Sponsor: Sawanpracharak hospital

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).

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 Timeline

• Study First Submitted: 2023-12-15
• Study First Submitted QC: 2023-12-15
• Study First Posted: 2023-12-29
• Study Start: 2024-02-04
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-17
• Primary Completion: 2024-07-04
• Study Completion: 2024-10-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lidocaine spray alone	Lidocaine Spray	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
receive lidocaine spray + lidocaine viscous solution	Lidocaine Viscous+Lidocane spray	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)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sawanpracharak hospital; 🇹🇭 Nakhon Sawan, Nakhonsawan, Thailand