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

Sawanpracharak hospital

Status: Invitation-only

Conditions: Pain; Satisfaction, Patient

Treatments: Drug: Lidocaine Spray; Drug: Lidocaine Viscous+Lidocane spray

Study type: Interventional

Funder types: Other

Identifiers

NCT06185933

NF01

Details and patient eligibility

About

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).

Full 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

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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250 participants in 2 patient groups

lidocaine spray alone

Active Comparator group

Description:

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

Treatment:

Drug: Lidocaine Spray

receive lidocaine spray + lidocaine viscous solution

Active Comparator group

Description:

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)

Treatment:

Drug: Lidocaine Viscous+Lidocane spray