Preoperative Viscous Lidocaine for Upper Gastrointestinal Endoscopy

Phase 4

Terminated

• Conditions: Anesthetics, Local; Esophagogastroduodenoscopy
• Interventions: Drug: Viscous Lidocaine

• Registration Number: NCT04725695
• Lead Sponsor: Bispebjerg Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-19
• Study First Submitted QC: 2021-01-23
• Study First Posted: 2021-01-27
• Study Start: 2022-03-29
• Primary Completion: 2023-12-15
• Study Completion: 2024-10-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 119

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Viscous lidocaine	Viscous Lidocaine	Oral viscous lidocaine 20 mg/ml, 10 ml
Placebo	Viscous Lidocaine	Oral viscous solution without active drug, 10 ml

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Endoscopy, Digestive Disease Center, Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark