Preoperative Viscous Lidocaine for Upper Gastrointestinal Endoscopy

NCT04725695 | Terminated Phase 4 DMC

• 1 other identifier: 2020-005177-27
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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

Conditions

Anesthetics, Local; Esophagogastroduodenoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Ease of examination

  Immediately after the procedure

• Number of intubation attempts

  Peroperatively counted by the assisting nurse

• Number of gag reflexes

  Peroperatively counted by the assisting nurse

• Patient's perception of discomfort

  Immediately after the procedure

• Patient's willingness to be reexamined

  Immediately after the procedure

Study Arms (2)

Viscous lidocaine

EXPERIMENTAL

Oral viscous lidocaine 20 mg/ml, 10 ml

Drug: Viscous Lidocaine

Placebo

PLACEBO COMPARATOR

Oral viscous solution without active drug, 10 ml

Drug: Viscous Lidocaine

Interventions

Viscous Lidocaine DRUG

The patients will be randomized to either viscous lidocaine or placebo

Placebo; Viscous lidocaine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bispebjerg Hospital: lead

Study Sites (1)

Department of Endoscopy, Digestive Disease Center, Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Erling Oma, MD, PhD

  Digestive Disease Center, Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 27, 2021
• Study Start: March 29, 2022
• Primary Completion: December 15, 2023
• Study Completion: October 30, 2024
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: After publication for 10 years
• Access Criteria: On demand

Locations

DK (1)