Study of Propofol Sedation During Upper Endoscopy With and Without Topical Pharyngeal Anesthesia
Overview
- Phase
- Phase 4
- Intervention
- Lidocaine 10%
- Conditions
- Conscious Sedation
- Sponsor
- University Hospital, Basel, Switzerland
- Enrollment
- 294
- Locations
- 2
- Primary Endpoint
- Number triggered gag reflex during the intubation of the endoscope
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Lukas Degen
Prof.
University Hospital, Basel, Switzerland
Eligibility 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
Arms & Interventions
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
Intervention: Lidocaine 10%
A with diluted gentian root solution
3 min before sedation 4 puffs of highly diluted gentian solution will be sprayed on the pharynx
Intervention: Diluted gentian root solution
Outcomes
Primary Outcomes
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 Outcomes
- The impact of the individual endoscopists or registered nurses involved in the endoscopy(After finishing the entire study)
- Overall assessment of the investigation by the patient(Immediately after recovery of consciousness of the patient)
- 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)
- Extent of amnesia in the patient(Immediately after recovery of consciousness of the patient)
- Experienced problems (aspiration, bronchospasm, desaturation)(From the start until the end of the exam)
- Assumption of the endoscopist if lidocaine or placebo has been used(Immediately after finishing the endoscopy)
- Overall assessment of the procedure by the endoscopist(Immediately after finishing the endoscopy)