Lidocaine Spray vs Viscous Lidocaine Solution Plus Lidocaine Spray in Patients Undergoing Non-Sedated Esophagogastroduodenoscopy: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Lidocaine Spray
- Conditions
- Pain
- Sponsor
- Sawanpracharak hospital
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- procedural pain, measured using the visual analog scale (VAS).
- Status
- Enrolling By Invitation
- Last Updated
- 2 years ago
Overview
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
Investigators
Natee Faknak
Clinical doctor at Department of medicine Sawanpracharak hospital
Sawanpracharak hospital
Eligibility Criteria
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.
Arms & Interventions
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
Intervention: Lidocaine Spray
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)
Intervention: Lidocaine Viscous+Lidocane spray
Outcomes
Primary Outcomes
procedural pain, measured using the visual analog scale (VAS).
Time Frame: 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 Outcomes
- patient tolerance(immediately after finished precedure)
- endoscopist satisfaction(immediately after finished precedure)
- patient satisfaction(30 minute after finished precedure)