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

Tracking Information

First Received Date ^ICMJE

May 6, 2011

Last Updated Date

July 4, 2012

Start Date ^ICMJE

September 2009

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01350050 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Topical Pharyngeal Anesthesia With Articaine for Gastroscopy

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Gastroscopy

Intervention ^ICMJE

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
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%

Study Arm (s)

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).

Intervention: Drug: articaine
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).

Intervention: Other: 9% Sodium Chloride solution for injection

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2009

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

healthy volunteers

Exclusion Criteria:

pregnancy
allergy to articaine, propofol, alfentanil

Gender

Both

Ages

20 Years to 70 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Finland

Administrative Information

NCT Number ^ICMJE

NCT01350050

Other Study ID Numbers ^ICMJE

a003c, 2009-011618-12

Has Data Monitoring Committee

Responsible Party

Maxim Mazanikov, Helsinki University Central Hospital

Study Sponsor ^ICMJE

Helsinki University Central Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Helsinki University Central Hospital

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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