Anesthetics, Local, Esophagogastroduodenoscopy
Conditions
Brief summary
In this randomized placebo-controlled clinical trial, patients will be randomized to be administered viscous lidocaine or placebo preoperatively to elective upper GI endoscopy
Interventions
DRUGViscous Lidocaine
The patients will be randomized to either viscous lidocaine or placebo
Sponsors
Bispebjerg Hospital
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 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients referred to and found fit for upper GI endoscopy in an out patient setting * Between 18 and 75 years old * Speaks and understands Danish
Exclusion criteria
* Patients admitted for upper GI endoscopy in an in-patient setting * Patients with dementia and/or other cognitive dysfunction disorders * Patients primarily complaining of dysphagia * Patients allergic to lidocaine * Patients with suspected retention * Patients who will undergo upper GI endoscopy with nurse-assisted propofol sedation * Patients who will undergo upper GI endoscopy with assistance of anesthesia-personnel
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ease of intubation | Immediately after the procedure | The endoscopist will rate the difficulty of intubating the esophagus on a numeric rating scale (NRS) from 0 (worst) to 10 (best) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of intubation attempts | Peroperatively counted by the assisting nurse | Total number of intubation attempts until the esophagus is reached |
| Number of gag reflexes | Peroperatively counted by the assisting nurse | Total number of gag reflexes during the examination |
| Patient's perception of discomfort | Immediately after the procedure | The patient's self-evaluation of discomfort during the examination on a numeric rating scale (NRS) from 0 (worst) to 10 (best) |
| Ease of examination | Immediately after the procedure | The endoscopist will rate the difficulty of performing the endoscopy on a numeric rating scale (NRS) from 0 (worst) to 10 (best) |
| Sedation 1 | Peroperatively | Number of milligrams midazolam administered during the procedure |
| Sedation 2 | Peroperatively | Number of milligrams alfentanil administered during the procedure |
| Perception of gag reflexes | Immediately after the procedure | The endoscopist's rating of the patient's degree of gag reflexes, numeric rating scale (NRS) from 0 (worst) to 10 (best) |
| Patient's willingness to be reexamined | Immediately after the procedure | The patient's willingness to have the procedure performed again in the future on a numeric rating scale (NRS) from 0 (worst) to 10 (best) |
Countries
Denmark
Outcome results
None listed