Propofol Sedation During Upper Endoscopy With and Without Topical Pharyngeal Anesthesia

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

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.

Study Overview

• Status: Completed
• Conditions: Conscious Sedation
• Intervention / Treatment: Drug: Lidocaine 10%; Drug: Diluted gentian root solution

• Study Type: Interventional
• Enrollment (Actual): 294
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • BS
    • Basel, BS, Switzerland, 4031
      • University Hospital; Division of Gastroenterology and Hepatology
  • ZH
    • Zollikerberg, ZH, Switzerland, 8125
      • Hospital of Zollikerberg, Internal Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Anesthesia (=A) with 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	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; Other Names: Xylocaine 10% spray
Placebo Comparator: A with diluted gentian root solution; 3 min before sedation 4 puffs of highly diluted gentian solution will be sprayed on the pharynx	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; Other Names: Gentian root extract, CAS no. 72968-42-4

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Ludwig T Heuss, MD, Spital Zollikerberg; Principal Investigator: Lukas Degen, Prof, University Hospital, Basel, Switzerland

Publications and helpful links

General Publications

• Heuss LT, Hanhart A, Dell-Kuster S, Zdrnja K, Ortmann M, Beglinger C, Bucher HC, Degen L. Propofol sedation alone or in combination with pharyngeal lidocaine anesthesia for routine upper GI endoscopy: a randomized, double-blind, placebo-controlled, non-inferiority trial. Gastrointest Endosc. 2011 Dec;74(6):1207-14. doi: 10.1016/j.gie.2011.07.072. Epub 2011 Oct 13.

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: March 2, 2010
• First Submitted That Met QC Criteria: March 4, 2010
• First Posted (Estimate): March 5, 2010

Study Record Updates

• Last Update Posted (Estimate): December 3, 2014
• Last Update Submitted That Met QC Criteria: December 2, 2014
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: Propofol; Anesthetics, Local; Conscious sedation; Topical pharyngeal anesthesia; Gastrointestinal Endoscopy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: EKBB 101/09