NCT01081002

Propofol Sedation During Upper Endoscopy With and Without Topical Pharyngeal Anesthesia

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 294 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Conscious Sedation

Interventions

Type	Name	Description
DRUG	Lidocaine 10%	3 min before the endoscopy under propofol sedation 4 puffs of lidocaine 10% will be sprayed on the pharynx as a pharyngeal anesthesia
DRUG	Diluted gentian root solution	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

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2010-03-05
• Last updated: 2014-12-03

Locations

2 sites across 1 country: Switzerland