Advantages of pharyngeal topical anaesthesia in sedated gastrointestinal endoscopy

Conditions: Propofol´s mean dosage in routinely esophagogastroduodenoscopy with and without topical pharyngeal anaesthesia with lidocaine. Variation between the patient´s groups in side effects and endoscopist and ansesthetist´s satisfaction.
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2011-005704-15-ES

Lead Sponsor: Hospital Universitario Infanta Cristina

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Patient´s over 18 years old that received standard indication for sedated esophagogastroduodenoscopy (American Society of Gastroinestinal Endoscopy Guidelines) in our centre between the period of study.
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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

-Patients under 18 years old
-Unable to obtain inform´s consent
-Emergency endoscopy
-Pregnant women
-Encephalopathy
-Well known allergic reaction to propofol, amide-anaesthesics, soy or eggs
-Methaemogloninemia induced factor risks
-No previous or unknown fasting

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Comparate mean dosage of propofol between similar groups of patients that receive placebo vs 50 mg of topical lidocaine before esophagogastroduodenoscopy.;Secondary Objective: -Incidence of side effects<br>-Satisfaction of endoscopist<br>-Satisfaction of anaesthetist<br>-Realationship with Mallampati´s index;Primary end point(s): -Reach the inclusion in the study of 120 patients prestablished (60 ASA I-II and 60 ASA III-IV) and double blind randomized between placebo and lidocaine groups.;Timepoint(s) of evaluation of this end point: 6 months

Secondary Outcome Measures