Topical Pharyngeal Anesthesia With Articaine for Gastroscopy

Helsinki University Central Hospital (HUCH)

Status and phase: Completed; Phase 4

Conditions: Gastroscopy

Treatments: Other: 9% Sodium Chloride solution for injection; Drug: articaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01350050

a003c

2009-011618-12 (EudraCT Number)

Details and patient eligibility

About

Topical Pharyngeal anesthesia (TPA) is widely used during upper endoscopy. Articaine is local anaesthetic that have not been previously evaluated in pharyngeal anesthesia for upper endoscopy. The aim of this study was to compare pharyngeal anesthesia with 4% articaine to placebo (Na0,9%) during gastroscopy in terms of benefit on patients' and endoscopists' satisfaction.

Full description

Topical Pharyngeal anesthesia (TPA) is widely used as an adjunct to sedation during upper endoscopy. TPA improves patient tolerance and the ease of endoscopy.1 Methemoglobinemia and anaphylactic reactions are serious complications of such topical anaesthetic agents, as lidocaine, tetracaine, and benzocaine. Articaine is as a unique amide local anaesthetic that possesses both an amide and an ester linkage and this is of clinical significance in minimizing the risk of overdose (toxic reaction). In routine dental procedures, articaine is a superior anaesthetic to lidocaine. Also, in comparison to lidocaine articaine acts faster and its duration of action is shorter what may be an advantage in such relatively fast procedures as gastroscopy. Articaine have not been previously evaluated in pharyngeal anesthesia for upper endoscopy. The aim of this randomised double-blind placebo controlled study was to compare pharyngeal anesthesia with 4% articaine to placebo (Na0,9%) during gastroscopy in terms of benefit on patients' and endoscopists'satisfaction.

Enrollment: 18 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy volunteers

Exclusion criteria

• pregnancy
• allergy to articaine, propofol, alfentanil

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

18 participants in 2 patient groups, including a placebo group

articaine

Active Comparator group

Description:

Pharyngeal anesthesia with articaine 4% or placebo should randomly and double-blindly applied in turns for every volunteer. In details: 3 ml of Articaine 4%solution or placebo (NaCl 0,9%) will be sprayed into the pharynx 5 minutes before beginning of gastroscopy. Also gastroscope will be lubricated with articaine (or placebo) gel(prepared by adding 4% articaine or 0,9%NaCl in placebo grope to Endopurin® endoscopic lubricant at the day of study).

Treatment:

Drug: articaine

placebo

Placebo Comparator group

Description:

Pharyngeal anesthesia with placebo or articaine 4% should be randomly and double-blindly applied in turns for every volunteer. In details: 3 ml of placebo or Articaine 4% solution should be sprayed into the pharynx 5 minutes before beginning of gastroscopy. Also gastroscope will be lubricated with placebo(or articaine) gel(prepared by adding 4% articaine or 0,9%NaCl in placebo grope to Endopurin® endoscopic lubricant at the day of study).

Treatment:

Other: 9% Sodium Chloride solution for injection