Tolerance
Conditions
Keywords
Lidocaine, Endoscopy, Tolerance
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.
Interventions
DRUGLidocaine
DRUGPlacebo
Placebo
Sponsors
Basque Health Service
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of tolerance referred by the endoscopist in each group. | Up to 15 minutes after endoscopy | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endoscopist's level of satisfaction with the procedure in each group | Up to 15 minutes after endoscopy | Endoscopist's level of satisfaction with the procedure according to a visual analogic scale |
| Patient's level of satisfaction with the procedure in each group. | Up to 15 minutes after endoscopy | Patient's level of satisfaction with the procedure according to a visual analogic scale |
| Number of completed procedures in control and lidocaine group | Up to 15 minutes after endoscopy | Number of completed procedures |
| Estimate the total dose of propofol used in each group | 15 minutes before endoscopy | Dose of propofol used |
| Degree of tolerance referred by the patient in each group | Up to 15 minutes after endoscopy | Establish degree of tolerance referred by the patient in each group according to the scale defined by Leich et al |
| Estimate the number of patients with retrograde amnesia in each group | Up to 15 minutes after endoscopy | Number of patients referring retrograde amnesia |
| Estimate the number of patients with cough in each group | Up to 15 minutes after endoscopy | Cough referred by the patient |
| Estimate the number of patients with oropharyngeal discomfort in each group. | Up to 15 minutes after endoscopy | Oropharyngeal discomfort referred by the patient |
| Establish and compare the number of adverse events detected in control and lidocaine group | Up to 15 minutes after endoscopy | Number of adverse events |
Countries
Spain
Outcome results
None listed