Propofol Sedation During Upper Endoscopy With and Without Topical Pharyngeal Anesthesia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lukas Degen, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01081002
First received: March 2, 2010
Last updated: December 2, 2014
Last verified: March 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Extent of salivation during intubation [ Time Frame: Start of the exam until the successful intubation of the esophagus with the endoscope ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Total amount of propofol used during the investigation [ Time Frame: From the start until the end of the exam ] [ Designated as safety issue: No ]
  • Overall assessment of the procedure by the endoscopist [ Time Frame: Immediately after finishing the endoscopy ] [ Designated as safety issue: No ]
  • Assumption of the endoscopist if lidocaine or placebo has been used [ Time Frame: Immediately after finishing the endoscopy ] [ Designated as safety issue: No ]
  • Overall assessment of the investigation by the patient [ Time Frame: Immediately after recovery of consciousness of the patient ] [ Designated as safety issue: No ]
  • Extent of amnesia in the patient [ Time Frame: Immediately after recovery of consciousness of the patient ] [ Designated as safety issue: No ]
  • Experienced problems (aspiration, bronchospasm, desaturation) [ Time Frame: From the start until the end of the exam ] [ Designated as safety issue: Yes ]
  • The impact of the individual endoscopists or registered nurses involved in the endoscopy [ Time Frame: After finishing the entire study ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: March 2, 2010
Last Updated: December 2, 2014
Health Authority: Switzerland: Ethikkommission

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

Additional relevant MeSH terms:
Pharmaceutical Solutions
Anesthetics
Propofol
Lidocaine
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
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

ClinicalTrials.gov processed this record on August 24, 2016