Clinical trial NCT01350050: Topical Pharyngeal Anesthesia With Articaine for Gastroscopy
Official title: Topical Pharyngeal Anaesthesia With Articaine for Gastroscopy. A Randomized Double-blind Study on Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastroscopy
Keywords: topical pharyngeal anesthesia
articaine
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2011-05-09
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* pregnancy
* allergy to articaine, propofol, alfentanil

Primary outcomes:
measure: satisfaction with gastroscopy
timeFrame: one day
Secondary outcomes:
measure: vital signs
timeFrame: one day
measure: easiness of gastroscopy performance
timeFrame: one day
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsiki University Central Hospital,Meilahti Hospital,Endoscopy unit
state: Uusimaa
Study officials:
affiliation: Helsinki University Central Hospital,Department of Anesthesiology and Intensive Care
name: Maxim Mazanikov, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital,Department of Anesthesiology and Intensive Care
name: Reino pöyhiä, MD,PhD
role: STUDY_DIRECTOR
affiliation: Helsinki University Central Hospital,Department of Gastrointestinal and General Surgery
name: Marianne Udd, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital,Department of Gastrointestinal and General Surgery
name: Jorma Halttunen, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital,Department of Gastrointestinal and General Surgery
name: Leena Kylänpää, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital,Department of Gastrointestinal and General Surgery
name: Outi Lindström, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital,Department of Medicine, Division of Gastroenterology
name: Martti Färkkilä, MD,Professor
role: PRINCIPAL_INVESTIGATOR
References: