Preoperative Viscous Lidocaine for Upper Gastrointestinal Endoscopy (LIDOGAS)

Preoperative Viscous Lidocaine for Upper Gastrointestinal Endoscopy - a Blinded, Randomized, Placebo-controlled Clinical Trial

In this randomized placebo-controlled clinical trial, patients will be randomized to be administered viscous lidocaine or placebo preoperatively to elective upper GI endoscopy

Study Overview

• Status: Terminated
• Conditions: Esophagogastroduodenoscopy; Anesthetics, Local
• Intervention / Treatment: Drug: Viscous Lidocaine

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2400
    • Department of Endoscopy, Digestive Disease Center, Bispebjerg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients referred to and found fit for upper GI endoscopy in an out patient setting
• Between 18 and 75 years old
• Speaks and understands Danish

Exclusion Criteria:

• Patients admitted for upper GI endoscopy in an in-patient setting
• Patients with dementia and/or other cognitive dysfunction disorders
• Patients primarily complaining of dysphagia
• Patients allergic to lidocaine
• Patients with suspected retention
• Patients who will undergo upper GI endoscopy with nurse-assisted propofol sedation
• Patients who will undergo upper GI endoscopy with assistance of anesthesia-personnel

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Viscous lidocaine; Oral viscous lidocaine 20 mg/ml, 10 ml	Drug: Viscous Lidocaine; The patients will be randomized to either viscous lidocaine or placebo
Placebo Comparator: Placebo; Oral viscous solution without active drug, 10 ml	Drug: Viscous Lidocaine; The patients will be randomized to either viscous lidocaine or placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of intubation	The endoscopist will rate the difficulty of intubating the esophagus on a numeric rating scale (NRS) from 0 (worst) to 10 (best)	Immediately after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of examination	The endoscopist will rate the difficulty of performing the endoscopy on a numeric rating scale (NRS) from 0 (worst) to 10 (best)	Immediately after the procedure
Number of intubation attempts	Total number of intubation attempts until the esophagus is reached	Peroperatively counted by the assisting nurse
Number of gag reflexes	Total number of gag reflexes during the examination	Peroperatively counted by the assisting nurse
Patient's perception of discomfort	The patient's self-evaluation of discomfort during the examination on a numeric rating scale (NRS) from 0 (worst) to 10 (best)	Immediately after the procedure
Patient's willingness to be reexamined	The patient's willingness to have the procedure performed again in the future on a numeric rating scale (NRS) from 0 (worst) to 10 (best)	Immediately after the procedure
Sedation 1	Number of milligrams midazolam administered during the procedure	Peroperatively
Sedation 2	Number of milligrams alfentanil administered during the procedure	Peroperatively
Perception of gag reflexes	The endoscopist's rating of the patient's degree of gag reflexes, numeric rating scale (NRS) from 0 (worst) to 10 (best)	Immediately after the procedure

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital
• Investigators: Principal Investigator: Erling Oma, MD, PhD, Digestive Disease Center, Bispebjerg Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2022
• Primary Completion (Actual): December 15, 2023
• Study Completion (Actual): October 30, 2024

Study Registration Dates

• First Submitted: January 19, 2021
• First Submitted That Met QC Criteria: January 23, 2021
• First Posted (Actual): January 27, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Lidocaine
• Other Study ID Numbers: 2020-005177-27

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: After publication for 10 years
• IPD Sharing Access Criteria: On demand
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No