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This study evaluates the efficacy and safety of the administration of lidocaine spray in oesophago-gastro-duodenoscopies. Half of the patients will receive lidocaine spray, while the other half will receive a placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine | Experimental | Five lidocaine solution puffs (10mg lidocaine/puff) on the four posterior quadrants of the pharynx and on the base of the tongue, 3 minutes before the oesophago-gastro-duodenoscopy. |
|
| Control | Placebo Comparator | Five placebo solution puffs on the four posterior quadrants of the pharynx and on the base of the tongue, 3 minutes before the oesophago-gastro-duodenoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of tolerance referred by the endoscopist in each group. | Establish degree of tolerance referred by the endoscopist in each group according to the scale defined by Leich et al ( Gastrointestinal Endosc 1993;39:384-7) | Up to 15 minutes after endoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of tolerance referred by the patient in each group | Establish degree of tolerance referred by the patient in each group according to the scale defined by Leich et al | Up to 15 minutes after endoscopy |
| Endoscopist's level of satisfaction with the procedure in each group |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Irene Martin Marcos, RN | Basque Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Araba University Hospital | Vitoria-Gasteiz | Alava | 01009 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34644419 | Derived | Martin-Marcos I, Fernandez-Morte N, Balsategui-Martin M, Ortiz-Cantero A, Bermudez-Ampudia C, Lopez-Picado A, Perez-Vaquero P, Salvador-Perez M, Cristobal-Dominguez E. Evaluation of pharyngeal lidocaine anesthesia for esophagogastroduodenoscopy: Double-blind randomized control trial. Dig Endosc. 2022 May;34(4):808-815. doi: 10.1111/den.14168. Epub 2021 Nov 17. |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Placebo |
|
Endoscopist's level of satisfaction with the procedure according to a visual analogic scale |
| Up to 15 minutes after endoscopy |
| Patient's level of satisfaction with the procedure in each group. | Patient's level of satisfaction with the procedure according to a visual analogic scale | Up to 15 minutes after endoscopy |
| Number of completed procedures in control and lidocaine group | Number of completed procedures | Up to 15 minutes after endoscopy |
| Estimate the total dose of propofol used in each group | Dose of propofol used | 15 minutes before endoscopy |
| Establish and compare the number of adverse events detected in control and lidocaine group | Number of adverse events | Up to 15 minutes after endoscopy |
| Estimate the number of patients with retrograde amnesia in each group | Number of patients referring retrograde amnesia | Up to 15 minutes after endoscopy |
| Estimate the number of patients with cough in each group | Cough referred by the patient | Up to 15 minutes after endoscopy |
| Estimate the number of patients with oropharyngeal discomfort in each group. | Oropharyngeal discomfort referred by the patient | Up to 15 minutes after endoscopy |
| Aniline Compounds |
| D000588 | Amines |