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

Pain Clinical Trial

Official title:

Lidocaine Spray vs Viscous Lidocaine Solution Plus Lidocaine Spray in Patients Undergoing Non-Sedated Esophagogastroduodenoscopy: A Randomized Controlled Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06185933
• Other study ID #: NF01
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 4, 2024
• Est. completion date: October 30, 2024

Study information

• Verified date: April 2024
• Source: Sawanpracharak hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 250
• Est. completion date: October 30, 2024
• Est. primary completion date: July 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain
• Satisfaction, Patient

Intervention

Drug:
• 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
• 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

Locations

Country	Name	City	State
Thailand	Sawanpracharak hospital	Nakhon Sawan	Nakhonsawan

Sponsors (1)

Lead Sponsor	Collaborator
Sawanpracharak hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	patient tolerance	1 = exceptional; 2 = well; 3 = fair; 4 = poor answer by endoscopist	immediately after finished precedure
Secondary	endoscopist satisfaction	1 = very satisfied; 2 = satisfied; 3 = neutral; and 4 = dissatisfied	immediately after finished precedure
Secondary	patient satisfaction	1 = very satisfied; 2 = satisfied; 3 = neutral; and 4 = dissatisfied	30 minute after finished precedure