Clinical trial NCT02733471: Evaluation of the Efficacy and Safety of Administering Lidocaine Spray in Oesophago-gastro-duodenoscopy
Official title: Evaluation of the Efficacy and Safety of Administering Lidocaine Spray in Oesophago-gastro-duodenoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tolerance
Keywords: Lidocaine
Endoscopy
Tolerance
Lead sponsor: Basque Health Service
Sponsor class: OTHER_GOV
First posted: 2016-04-11
Enrollment: 586
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion criteria:

* Patients aged over 18
* ASA I, II and III
* Non allergic to lidocaine or any of the drugs used in the study
* Consent form signed by the patient

Exclusion Criteria:

* Stomach or esophagus diagnosed cancer
* Giant hiatal hernia diagnosed
* Zenker's diverticulum diagnosed
* Achalasia diagnosed
* Patients aged over 70
* Medical history of moderate to severe liver disease
* Medical history of moderate to severe renal insufficiency
* Medical history of moderate to severe Obstructive Sleep Apnea Syndrome (OSA) (AHI≥15).
* Severe respiratory insufficiency(asmtha or COPD) diagnosed
* Patients with encephalopaty active
* Patients with medical history of methemoglobinemia
* Patients with history of drug abuse
* Patients with mental impairment
* Patients with BMI≥ 35
* Use of pediatric tube

Primary outcomes:
measure: Degree of tolerance referred by the endoscopist in each group.
timeFrame: Up to 15 minutes after endoscopy
Secondary outcomes:
measure: Degree of tolerance referred by the patient in each group
timeFrame: Up to 15 minutes after endoscopy
measure: Endoscopist's level of satisfaction with the procedure in each group
timeFrame: Up to 15 minutes after endoscopy
measure: Patient's level of satisfaction with the procedure in each group.
timeFrame: Up to 15 minutes after endoscopy
measure: Number of completed procedures in control and lidocaine group
timeFrame: Up to 15 minutes after endoscopy
measure: Estimate the total dose of propofol used in each group
timeFrame: 15 minutes before endoscopy
measure: Establish and compare the number of adverse events detected in control and lidocaine group
timeFrame: Up to 15 minutes after endoscopy
measure: Estimate the number of patients with retrograde amnesia in each group
timeFrame: Up to 15 minutes after endoscopy
measure: Estimate the number of patients with cough in each group
timeFrame: Up to 15 minutes after endoscopy
measure: Estimate the number of patients with oropharyngeal discomfort in each group.
timeFrame: Up to 15 minutes after endoscopy
Other outcomes:
Locations:
city: Vitoria
country: Spain
facility: Araba University Hospital
state: Alava
Study officials:
affiliation: Basque Health System
name: Irene Martin Marcos, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.