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Lack of ressources
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In this randomized placebo-controlled clinical trial, patients will be randomized to be administered viscous lidocaine or placebo preoperatively to elective upper GI endoscopy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Viscous lidocaine | Experimental | Oral viscous lidocaine 20 mg/ml, 10 ml |
|
| Placebo | Placebo Comparator | Oral viscous solution without active drug, 10 ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Viscous Lidocaine | Drug | The patients will be randomized to either viscous lidocaine or placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ease of intubation | The endoscopist will rate the difficulty of intubating the esophagus on a numeric rating scale (NRS) from 0 (worst) to 10 (best) | Immediately after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Ease of examination | The endoscopist will rate the difficulty of performing the endoscopy on a numeric rating scale (NRS) from 0 (worst) to 10 (best) | Immediately after the procedure |
| Number of intubation attempts |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erling Oma, MD, PhD | Digestive Disease Center, Bispebjerg Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Endoscopy, Digestive Disease Center, Bispebjerg Hospital | Copenhagen | 2400 | Denmark |
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After publication for 10 years
On demand
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Total number of intubation attempts until the esophagus is reached
| Peroperatively counted by the assisting nurse |
| Number of gag reflexes | Total number of gag reflexes during the examination | Peroperatively counted by the assisting nurse |
| Patient's perception of discomfort | The patient's self-evaluation of discomfort during the examination on a numeric rating scale (NRS) from 0 (worst) to 10 (best) | Immediately after the procedure |
| Patient's willingness to be reexamined | 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) | Immediately after the procedure |
| Sedation 1 | Number of milligrams midazolam administered during the procedure | Peroperatively |
| Sedation 2 | Number of milligrams alfentanil administered during the procedure | Peroperatively |
| Perception of gag reflexes | The endoscopist's rating of the patient's degree of gag reflexes, numeric rating scale (NRS) from 0 (worst) to 10 (best) | Immediately after the procedure |
| Aniline Compounds |
| D000588 | Amines |