Usefulness of Lidocaine as Topical Pharyngeal Anaesthesia in Esophagogastroduodenoscopy Under Sedation With Propofol

Hospital Universitario Infanta Cristina

Status and phase: Completed; Phase 4

Conditions: Esophagogastroduodenoscopy

Treatments: Drug: Placebo; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01489891

ATF-EGD001

2011-005704-15

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

120 participants in 2 patient groups, including a placebo group

Lidocaine group

Active Comparator group

Description:

Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated esophagogastroduodenoscopy (EGD)

Treatment:

Drug: Lidocaine

Placebo

Placebo Comparator group

Description:

Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.

Treatment:

Drug: Placebo