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Topical Pharyngeal Anesthesia With Articaine for Gastroscopy

NCT ID: NCT01350050

Last Updated: 2012-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2009-12-31

Brief Summary

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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

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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.

Conditions

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Gastroscopy

Keywords

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topical pharyngeal anesthesia articaine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

articaine

Intervention Type DRUG

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.

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).

Group Type PLACEBO_COMPARATOR

9% Sodium Chloride solution for injection

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type OTHER

Other Intervention Names

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Septocaine Articadent NaCl 0.9%

Eligibility Criteria

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Inclusion Criteria

* healthy volunteers

Exclusion Criteria

* pregnancy
* allergy to articaine, propofol, alfentanil
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Maxim Mazanikov

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maxim Mazanikov, MD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital,Department of Anesthesiology and Intensive Care

Reino pöyhiä, MD,PhD

Role: STUDY_DIRECTOR

Helsinki University Central Hospital,Department of Anesthesiology and Intensive Care

Marianne Udd, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital,Department of Gastrointestinal and General Surgery

Jorma Halttunen, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital,Department of Gastrointestinal and General Surgery

Leena Kylänpää, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital,Department of Gastrointestinal and General Surgery

Outi Lindström, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital,Department of Gastrointestinal and General Surgery

Martti Färkkilä, MD,Professor

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital,Department of Medicine, Division of Gastroenterology

Locations

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Helsiki University Central Hospital,Meilahti Hospital,Endoscopy unit

Helsinki, Uusimaa, Finland

Site Status

Countries

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Finland

Other Identifiers

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2009-011618-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

a003c

Identifier Type: -

Identifier Source: org_study_id