Preoperative Viscous Lidocaine for Upper Gastrointestinal Endoscopy

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

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

Conditions
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Anesthetics, Local, Esophagogastroduodenoscopy

Intervention / Treatment
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* Drug: Viscous Lidocaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |