Propofol Sedation During Upper Endoscopy With and Without Topical Pharyngeal Anesthesia

Phase 4

Completed

• Conditions: Conscious Sedation
• Interventions: Drug: Diluted gentian root solution; Drug: Lidocaine 10%

• Registration Number: NCT01081002
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Status Verified: 2010-03
• Study First Submitted: 2010-03-02
• Study First Submitted QC: 2010-03-04
• Study First Posted: 2010-03-05
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 294

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A with diluted gentian root solution	Diluted gentian root solution	3 min before sedation 4 puffs of highly diluted gentian solution will be sprayed on the pharynx
Anesthesia (=A) with lidocaine 10%	Lidocaine 10%	3 min before sedation 4 puffs of terbutaline diluted lidocaine solution (Xylocaine ® 10% spray, Astra Zeneca, London, UK) will be sprayed on the pharynx

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
The impact of the individual endoscopists or registered nurses involved in the endoscopy	After finishing the entire study
Overall assessment of the investigation by the patient	Immediately after recovery of consciousness of the patient
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
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
Assumption of the endoscopist if lidocaine or placebo has been used	Immediately after finishing the endoscopy
Overall assessment of the procedure by the endoscopist	Immediately after finishing the endoscopy

Trial Locations

Locations (2)

University Hospital; Division of Gastroenterology and Hepatology; 🇨🇭 Basel, BS, Switzerland

Hospital of Zollikerberg, Internal Medicine; 🇨🇭 Zollikerberg, ZH, Switzerland