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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-04

Study Completion Date

2024-10-30

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).

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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

Conditions

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Pain Satisfaction, Patient

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Lidocaine Spray

Intervention Type 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

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)

Group Type ACTIVE_COMPARATOR

Lidocaine Viscous+Lidocane spray

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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liocaine spray Lidocaine Viscous Lidocane spray

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No