Elective gastroscopy MedDRA version: 18.0 Level: LLT Classification code 10018047 Term: Gastroscopy System Organ Class: 100000004848
Conditions
Interventions
Trade Name: Xilonibsa
Pharmaceutical Form:
INN or Proposed INN: Lidocaine
CAS Number: 6108-05-0
Concentration unit: % percent
Sponsors
BASQUE HEALTH SYSTEM
Eligibility
Sex/Gender
All
Inclusion 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 -Conset form signed by the patient Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 52
Exclusion criteria
Exclusion criteria: -Pregnancy or lactation -Patients aged over 70 -Poorly controlled insulin-treated type I or II diabetes (Hb1Ac=8). -Moderate to severe liver disease -Moderate to severe renal insufficiency -Moderate to severe Obstructive Sleep Apnea Syndrome (OSA) (AHI=15). -Severe respiratory insufficiency -Open angle glaucoma -Patients with encephalopaty -Patients with medical history of methemoglobinemia -Patients with history of drug or alcohol abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Establish the degree of tolerance referred by the endoscopist in each group.;Timepoint(s) of evaluation of this end point: End of gastroscopy; Secondary Objective: 1. Establish the degree of tolerance referred by the patient in each group. 2. Compare the endoscopist's level of satisfaction with the procedure in each group. 3. Compare the patient's level of satisfaction with the procedure in each group. 4. Analize the number of completed procedures in both control and lidocaine group. 5. Estimate the total dose of propofol used in each group. 6. Compare the number of adverse events detected in both control and lidocaine group. 7. Establish the number of patients referring retrograde amnesia in each group. 8. Establish the number of adverse events. 9. Compare the cough referred by the patient after the procedure in each group. 10. Compare oropharyngeal discomfort referred by the patient after the procedure in each group ; Primary end point(s): Degree of tolerance reported by endoscopist:A scale based on the one used by Leich et al(Gastrointest Endosc. 1993;39:384-7) will be utilized in order to determine this objective. In this scale, degree of tolerance is classified into 4 categories (1 = well tolerated, easy intubation, completed procedure; 4 = poor tolerated, incomplete procedure or unrealized). If the endoscopist values the gastroscopy as "well tolerated, easy intubation, completed procedure" or "Good tolerance, difficult or hindered intubation, completed procedure" (categories 1 and 2), it will be considered optimally tolerated. On the contrary, if the responsible specialist values the gastroscopy as "Badly tolerated, completed procedure" or "Badly tolerated, incomplete or unrealized procedure", it will be regarded as poorly to | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Degree of tolerance reported by the patient. A scale based on the one used by Leich et al will be utilized in order to determine this criterion. In this scale, degree of tolerance is classified into 4 categories (1=well tolerated, would repeat the procedure; 4=badly tolerated, would not repeat the procedure). If the patient values the gastroscopy as "well tolerated, would repeat the procedure" or "well tolerated, would not repeat the procedure" (categories 1 and 2), it will be considered optimally tolerated. On the contrary, if the responsible patient values the gastroscopy as "Badly tolerated, would repeat the procedure" or "Badly tolerated, would not repeat the procedure",(categories 3 and 4) it will be regarded as poorly tolerated. - Endoscopist's level of satisfaction with the procedure. A visual analog scale that assesses physician satisfaction with the procedure will be used. The evaluation will be between 0-10 (0 not at all satisfied and 10 fully satisfied). - Patient's level of satisfaction with the procedure. A visual analog scale that assesses patient satisfaction with the procedure will be used. The evaluation will be between 0-10 (0 not at all satisfied and 10 fully satisfied). - Number of completed procedures. We will work within the rating scale aforementioned in the main objective in order to establish the number of completed procedures. The procedure will be considered as completed in case categories 1 or 2 (?well tolerated, easy intubation, completed procedure? or ?Good tolerance, difficult or hindered intubation, completed procedure?) are selected by the endoscopist. - Total dose of propofol used: Both initial dose (40mg) as all boluses administered during the procedure (20mg/bolus) will be counted. - Number of detected adverse events: all adverse | — |
Countries
Spain
Contacts
Public ContactIRENE MARTIN MARCOS
ARABA UNIVERSITY HOSPITAL
Outcome results
None listed