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Propofol Sedation During Upper Endoscopy With and Without Topical Pharyngeal Anesthesia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01081002
First Posted: March 5, 2010
Last Update Posted: December 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lukas Degen, University Hospital, Basel, Switzerland
  Purpose

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.


Condition Intervention Phase
Conscious Sedation Drug: Lidocaine 10% Drug: Diluted gentian root solution Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Study of Propofol Sedation During Upper Endoscopy With and Without Topical Pharyngeal Anesthesia

Resource links provided by NLM:


Further study details as provided by Lukas Degen, University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Number triggered gag reflex during the intubation of the endoscope [ Time Frame: 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 [ Time Frame: Start of the exam until the successful intubation of the esophagus with the endoscope ]
  • Extent of salivation during intubation [ Time Frame: Start of the exam until the successful intubation of the esophagus with the endoscope ]

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

Enrollment: 294
Study Start Date: August 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Gentian root extract, CAS no. 72968-42-4

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01081002


Locations
Switzerland
University Hospital; Division of Gastroenterology and Hepatology
Basel, BS, Switzerland, 4031
Hospital of Zollikerberg, Internal Medicine
Zollikerberg, ZH, Switzerland, 8125
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Ludwig T Heuss, MD Spital Zollikerberg
Principal Investigator: Lukas Degen, Prof University Hospital, Basel, Switzerland
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lukas Degen, Prof., University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01081002     History of Changes
Other Study ID Numbers: EKBB 101/09
First Submitted: March 2, 2010
First Posted: March 5, 2010
Last Update Posted: December 3, 2014
Last Verified: March 2010

Keywords provided by Lukas Degen, University Hospital, Basel, Switzerland:
Propofol
Conscious sedation
Topical pharyngeal anesthesia
Anesthetics, Local
Gastrointestinal Endoscopy

Additional relevant MeSH terms:
Pharmaceutical Solutions
Anesthetics
Lidocaine
Propofol
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General