Propofol Sedation During Upper Endoscopy With and Without Topical Pharyngeal Anesthesia

Study Overview
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Brief Summary
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It is unclear whether a topical pharyngeal anesthesia adds any benefit to the upper gastrointestinal endoscopy under a propofol sedation. We hypothesize that a topical pharyngeal anesthesia does not ease the upper gastrointestinal endoscopy under propofol sedation. The aim of this study is therefore to quantify the impact of a topical pharyngeal anesthesia to the upper gastrointestinal endoscopy in patients sedated with propofol. Patients will be randomized to receive a topical pharyngeal spray containing either an anesthetic drug (lidocaine 10%) or a placebo. Thereafter the upper endoscopy will be conducted in its standard manner.

Official Title
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Study of Propofol Sedation During Upper Endoscopy With and Without Topical Pharyngeal Anesthesia

Conditions
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Conscious Sedation

Intervention / Treatment
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* Drug: Lidocaine 10%
* Drug: Diluted gentian root solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled diagnostic upper endoscopy Wish to be sedated ASA class I - III Signed informed consent Exclusion Criteria: Emergency medical examinations Therapeutic Endoscopy ASA class IV Pregnancy Known allergy to propofol or lidocaine

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Active Comparator: Anesthesia (=A) with lidocaine 10%<br>3 min before sedation 4 puffs of terbutaline diluted lidocaine solution (Xylocaine ® 10% spray, Astra Zeneca, London, UK) will be sprayed on the pharynx | Drug: Lidocaine 10%<br>* 3 min before the endoscopy under propofol sedation 4 puffs of lidocaine 10% will be sprayed on the pharynx as a pharyngeal anesthesia<br>* Other names: Xylocaine 10% spray;|
| Placebo Comparator: A with diluted gentian root solution<br>3 min before sedation 4 puffs of highly diluted gentian solution will be sprayed on the pharynx | Drug: Diluted gentian root solution<br>* As a basis, an infusion of water (45%), ethanol (35%) and gentian root cut will be used. The gentian root infusion is approved as a natural flavor in the food industry.3 min before the endoscopy under propofol sedation 4 puffs of this gentian root infusion will be sprayed on the pharynx as a pharyngeal anesthesia<br>* Other names: Gentian root extract, CAS no. 72968-42-4;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number triggered gag reflex during the intubation of the endoscope |  | Start of the exam until the successful intubation of the esophagus with the endoscope | 
| Number of attempts of intubation with the endoscope through the upper esophageal sphincter |  | Start of the exam until the successful intubation of the esophagus with the endoscope | 
| Extent of salivation during intubation |  | Start of the exam until the successful intubation of the esophagus with the endoscope | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of propofol used to successfully intubate the esophagus |  | Start of the exam until the successful intubation of the esophagus with the endoscope | 
| Total amount of propofol used during the investigation |  | From the start until the end of the exam | 
| Overall assessment of the procedure by the endoscopist |  | Immediately after finishing the endoscopy | 
| Assumption of the endoscopist if lidocaine or placebo has been used |  | Immediately after finishing the endoscopy | 
| Overall assessment of the investigation by the patient |  | Immediately after recovery of consciousness of the patient | 
| Extent of amnesia in the patient |  | Immediately after recovery of consciousness of the patient | 
| Experienced problems (aspiration, bronchospasm, desaturation) |  | From the start until the end of the exam | 
| The impact of the individual endoscopists or registered nurses involved in the endoscopy |  | After finishing the entire study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Propofol, Conscious sedation, Topical pharyngeal anesthesia, Anesthetics, Local, Gastrointestinal Endoscopy