Oral pharyngeal anesthesia for Upper Gastrointestinal Endoscopy

Phase 1

• Conditions: Topical local anesthesia for upper gastrointestinal endoscopy; MedDRA version: 21.1Level: LLTClassification code 10024760Term: Local anestheticSystem Organ Class: 100000004865; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2020-005177-27-DK
• Lead Sponsor: Bispebjerg Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-16
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 248

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 48

Exclusion Criteria

Patients admitted for upper GI endoscopy in an in-patient setting
Patients with dementia and/or other cognitive dysfunction disorders
Patients primarly 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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine if placebo is non-inferior to viscous lidocaine for upper gastrointestinal endoscopy;Secondary Objective: Not applicable;Primary end point(s): Ease of intubation [Time Frame: Immediately after the procedure]<br>The endocopist will rate the difficulty of intubating the esophagus on a numeric rating scale NRS 0-10;Timepoint(s) of evaluation of this end point: Immediately after the procedure