Topical Pharyngeal Anesthesia With Articaine for Gastroscopy

Topical Pharyngeal Anaesthesia With Articaine for Gastroscopy. A Randomized Double-blind Study on Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Gastroscopy
• Intervention / Treatment: Drug: articaine; Other: 9% Sodium Chloride solution for injection

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 4

Contacts and Locations

Study Locations

• Finland
  • Uusimaa
    • Helsinki, Uusimaa, Finland, 00029
      • Helsiki University central Hospital,Meilahti Hospital,Endoscopy unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• healthy volunteers

Exclusion Criteria:

• pregnancy
• allergy to articaine, propofol, alfentanil

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: articaine; 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).	Drug: articaine; Articaine is intermediate-acting local anesthetic (amide type). Like other local anesthetic drugs, articaine causes a transient and completely reversible state of anesthesia (loss of sensation) during (dental) procedures. In dentistry, articaine is used both for infiltration and block injections.; Other Names: Septocaine; Articadent
Placebo Comparator: placebo; 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).	Other: 9% Sodium Chloride solution for injection; 9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. Each mL contains sodium chloride 9 mg. It contains no bacteriostat, antimicrobial agent or added buffer.; Other Names: NaCl 0.9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
satisfaction with gastroscopy	Volunteers were asked to evaluate unpleasantness of gastroscopy (0- most unpleasant, 10-most pleasant), overall satisfaction with gastroscopy (0-extremely dissatisfied 7-extremely satisfied)	one day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
vital signs	Vital signs (heart rate, electrocardiogram, non-invasive blood pressure, peripheral oxygen saturation, end-expiratory carbon dioxide) will be monitored during the gastroscopy and until the discharge.	one day
easiness of gastroscopy performance	The easiness of gastroscopy performance will be evaluated by endoscopists' with structured questionnaire.	one day

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Investigators: Study Director: Reino pöyhiä, MD,PhD, Helsinki University Central Hospital,Department of Anesthesiology and Intensive Care

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: May 6, 2011
• First Submitted That Met QC Criteria: May 6, 2011
• First Posted (Estimate): May 9, 2011

Study Record Updates

• Last Update Posted (Estimate): July 6, 2012
• Last Update Submitted That Met QC Criteria: July 4, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: articaine; topical pharyngeal anesthesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Carticaine
• Other Study ID Numbers: a003c; 2009-011618-12 (EudraCT Number)