Propofol Sedation During Upper Endoscopy With and Without Topical Pharyngeal Anesthesia

NCT01081002 | Completed Phase 4

• 1 other identifier: EKBB 101/09
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 2

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.

Conditions

Conscious Sedation

Keywords

Propofol; Conscious sedation; Topical pharyngeal anesthesia; Anesthetics, Local; Gastrointestinal Endoscopy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• 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

Study Arms (2)

Anesthesia (=A) with lidocaine 10%

ACTIVE COMPARATOR

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%

A with diluted gentian root solution

PLACEBO COMPARATOR

3 min before sedation 4 puffs of highly diluted gentian solution will be sprayed on the pharynx

Drug: Diluted gentian root solution

Interventions

Lidocaine 10% DRUG

3 min before the endoscopy under propofol sedation 4 puffs of lidocaine 10% will be sprayed on the pharynx as a pharyngeal anesthesia

Also known as: Xylocaine 10% spray

Anesthesia (=A) with lidocaine 10%

Diluted gentian root solution DRUG

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

Also known as: Gentian root extract, CAS no. 72968-42-4

A with diluted gentian root solution

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled diagnostic upper endoscopy
• Wish to be sedated
• ASA class I - III
• Signed informed consent

You may not qualify if:

• Emergency medical examinations
• Therapeutic Endoscopy
• ASA class IV
• Pregnancy
• Known allergy to propofol or lidocaine

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (2)

University Hospital; Division of Gastroenterology and Hepatology

Basel, Canton of Basel-City, 4031, Switzerland

Location

Hospital of Zollikerberg, Internal Medicine

Zollikerberg, Canton of Zurich, 8125, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 22000794 DERIVED

MeSH Terms

Interventions

Lidocaine; gentian root extract

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Ludwig T Heuss, MD

  Spital Zollikerberg

  PRINCIPAL INVESTIGATOR

• Lukas Degen, Prof

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: March 2, 2010
• First Posted: March 5, 2010
• Study Start: August 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: December 3, 2014

Record last verified: 2010-03

Locations

CH (2)