Usefulness of Applying Lidocaine as Topical Pharyngeal Anaesthesia in Esophagogastroduodenoscopies Performed Under Sedation With Propofol- a Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Rate of Administration of Propofol 1% Required to Obtain Uniform Sedation During Endoscopy
Study Overview
Brief Summary
The purpose of this study is to determine the efficacy of application of the anaesthesia topical pharyngeal with lidocaine in esophagogastroduodenoscopy under propofol´s sedation, in therms of dosage and side effect´s reduction overall.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patient´s over 18 years old that received standard indication for sedated esophagogastroduodenoscopy (American Society of Gastrointestinal Endoscopy Guidelines) in our centre between the period of study.
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
- •Methaemoglobinemia induced factor risks
- •No previous or unknown fasting
Arms & Interventions
Lidocaine group
Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated esophagogastroduodenoscopy (EGD)
Intervention: Lidocaine (Drug)
Placebo
Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Rate of Administration of Propofol 1% Required to Obtain Uniform Sedation During Endoscopy
Time Frame: 8 months
The propofol will be administered by an expert anaesthetist in repeated bolus (10-20 mg each 30-60 seconds) after an initial induction dosage (0.5-0.6 mg/kg ASA (American Society of Anaesthesiologists) I-II or 0.25-0.35 mg/kg ASA III-IV) to obtain an uniform level of sedation (OAAS 3 and bispectral index (BIS) 70-80) and adequate perceived patient tolerance (no gag-reflex, cough, sudden movements).
Secondary Outcomes
- Percentage of Participants With Adverse Events in Both Groups(Participants will be followed for the duration of hospital stay, an expected average of 2 hours postprocedure)
- Likert Four Elements Scale to Evaluate the Satisfaction of Endoscopist(8 months)
- Likert Four Elements Scale to Evaluate the Satisfaction of Anaesthetist(8 months)
Investigators
Felipe de la Morena Lopez MD
Gastroenterologist. Head of endoscopy
Hospital Universitario Infanta Cristina