Conscious Sedation
Conditions
Keywords
Propofol, Conscious sedation, Topical pharyngeal anesthesia, Anesthetics, Local, Gastrointestinal Endoscopy
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.
Interventions
DRUGLidocaine 10%
3 min before the endoscopy under propofol sedation 4 puffs of lidocaine 10% will be sprayed on the pharynx as a pharyngeal anesthesia
DRUGDiluted 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
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number triggered gag reflex during the intubation of the endoscope | 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 | Start of the exam until the successful intubation of the esophagus with the endoscope |
| Extent of salivation during intubation | Start of the exam until the successful intubation of the esophagus with the endoscope |
Secondary
| Measure | Time frame |
|---|---|
| Assumption of the endoscopist if lidocaine or placebo has been used | Immediately after finishing the endoscopy |
| 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 |
| Experienced problems (aspiration, bronchospasm, desaturation) | From the start until the end of the exam |
| The impact of the individual endoscopists or registered nurses involved in the endoscopy | After finishing the entire study |
| Extent of amnesia in the patient | Immediately after recovery of consciousness of the patient |
| Total amount of propofol used during the investigation | From the start until the end of the exam |
| Overall assessment of the procedure by the endoscopist | Immediately after finishing the endoscopy |
Countries
Switzerland
Outcome results
None listed