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Topical Pharyngeal Anesthesia With Articaine for Gastroscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maxim Mazanikov, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01350050
First received: May 6, 2011
Last updated: July 4, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Gastroscopy
 Drug: articaine
Other: 9% Sodium Chloride solution for injection
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Topical Pharyngeal Anaesthesia With Articaine for Gastroscopy. A Randomized Double-blind Study on Volunteers

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • satisfaction with gastroscopy [ Time Frame: one day ] [ Designated as safety issue: No ]
    Volunteers were asked to evaluate unpleasantness of gastroscopy (0- most unpleasant, 10-most pleasant), overall satisfaction with gastroscopy (0-extremely dissatisfied 7-extremely satisfied)


Secondary Outcome Measures:
  • vital signs [ Time Frame: one day ] [ Designated as safety issue: Yes ]
    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.

  • easiness of gastroscopy performance [ Time Frame: one day ] [ Designated as safety issue: No ]
    The easiness of gastroscopy performance will be evaluated by endoscopists` with structured questionnaire.


Enrollment: 18
Study Start Date: September 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: NaCl 0.9%

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

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy volunteers

Exclusion Criteria:

  • pregnancy
  • allergy to articaine, propofol, alfentanil
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01350050

Locations
Finland
Helsiki University Central Hospital,Meilahti Hospital,Endoscopy unit
Helsinki, Uusimaa, Finland, 00029
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
Principal Investigator: Maxim Mazanikov, MD Helsinki University Central Hospital,Department of Anesthesiology and Intensive Care
Study Director: Reino pöyhiä, MD,PhD Helsinki University Central Hospital,Department of Anesthesiology and Intensive Care
Principal Investigator: Marianne Udd, MD,PhD Helsinki University Central Hospital,Department of Gastrointestinal and General Surgery
Principal Investigator: Jorma Halttunen, MD,PhD Helsinki University Central Hospital,Department of Gastrointestinal and General Surgery
Principal Investigator: Leena Kylänpää, MD,PhD Helsinki University Central Hospital,Department of Gastrointestinal and General Surgery
Principal Investigator: Outi Lindström, MD,PhD Helsinki University Central Hospital,Department of Gastrointestinal and General Surgery
Principal Investigator: Martti Färkkilä, MD,Professor Helsinki University Central Hospital,Department of Medicine, Division of Gastroenterology
  More Information

No publications provided

Responsible Party: Maxim Mazanikov, M.D., Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01350050     History of Changes
Other Study ID Numbers: a003c, 2009-011618-12
Study First Received: May 6, 2011
Last Updated: July 4, 2012
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Helsinki University Central Hospital:
topical pharyngeal anesthesia
articaine

Additional relevant MeSH terms:
Anesthetics
Carticaine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on June 18, 2013