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Completed

NCT Number: NCT01081002

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.

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Key information

Conditions

Conscious Sedation

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital; Division of Gastroenterology and Hepatology, Basel, Canton of Basel-City, Switzerland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Xylocaine 10% spray

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

Other names: Gentian root extract, CAS no. 72968-42-4

Primary outcomes

  1. 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

  2. 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

  3. Extent of salivation during intubation

    Time frame: Start of the exam until the successful intubation of the esophagus with the endoscope

Secondary outcomes

  1. 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

  2. Total amount of propofol used during the investigation

    Time frame: From the start until the end of the exam

  3. Overall assessment of the procedure by the endoscopist

    Time frame: Immediately after finishing the endoscopy

  4. Assumption of the endoscopist if lidocaine or placebo has been used

    Time frame: Immediately after finishing the endoscopy

  5. Overall assessment of the investigation by the patient

    Time frame: Immediately after recovery of consciousness of the patient

  6. Extent of amnesia in the patient

    Time frame: Immediately after recovery of consciousness of the patient

  7. Experienced problems (aspiration, bronchospasm, desaturation)

    Time frame: From the start until the end of the exam

  8. The impact of the individual endoscopists or registered nurses involved in the endoscopy

    Time frame: After finishing the entire study

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 5, 2010
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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