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Propofol Sedation During Upper Endoscopy With and Without Topical Pharyngeal Anesthesia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by University Hospital, Basel, Switzerland.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01081002
First received: March 2, 2010
Last updated: March 4, 2010
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 ]

Estimated Enrollment: 270
Study Start Date: October 2009
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Anesthesia 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: Anesthesia with 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
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

Contacts
Contact: Ludwig Heuss, MD +41 44 397 20 12 ludwig.heuss@spitalzollikerberg.ch
Contact: Lukas Degen, Prof +41 61 265 51 74 lukas.degen@unibas.ch

Locations
Switzerland
University Hospital; Division of Gastroenterology and Hepatology Recruiting
Basel, BS, Switzerland, 4031
Contact: Lukas Degen, Prof    +41 61 265 51 74    lukas.degen@unibas.ch   
Principal Investigator: Lukas Degen, Prof         
Sub-Investigator: Michael Manz, MD         
Hospital of Zollikerberg, Internal Medicine Recruiting
Zollikerberg, ZH, Switzerland, 8125
Contact: Ludwig Heuss, MD    +41 44 397 20 12    ludwig.heuss@spitalzollikerberg.ch   
Principal Investigator: Ludwig Heuss, MD         
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

No publications provided by University Hospital, Basel, Switzerland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lukas Degen, Prof, University Hospital Basel, Division of Gastroenterology and Hepatology, Switzerland
ClinicalTrials.gov Identifier: NCT01081002     History of Changes
Other Study ID Numbers: EKBB 101/09
Study First Received: March 2, 2010
Last Updated: March 4, 2010
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:
Anesthetics
Lidocaine
Pharmaceutical Solutions
Propofol
Anesthetics, General
Anesthetics, Intravenous
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on November 19, 2014