Topical Pharyngeal Anesthesia With Articaine for Gastroscopy

NCT01350050 | Completed Phase 4

• 2 other identifiers: a003c2009-011618-12
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroscopy

Keywords

topical pharyngeal anesthesia; articaine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• vital signs

  one day

• easiness of gastroscopy performance

  one day

Study Arms (2)

articaine

ACTIVE COMPARATOR

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

placebo

PLACEBO COMPARATOR

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

Interventions

articaine 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.

Also known as: Septocaine, Articadent

articaine

9% Sodium Chloride solution for injection 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.

Also known as: NaCl 0.9%

placebo

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy volunteers

You may not qualify if:

• pregnancy
• allergy to articaine, propofol, alfentanil

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

Helsiki University Central Hospital,Meilahti Hospital,Endoscopy unit

Helsinki, Uusimaa, 00029, Finland

Location

MeSH Terms

Interventions

Carticaine; Sodium Chloride; Injections

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Maxim Mazanikov, MD

  Helsinki University Central Hospital,Department of Anesthesiology and Intensive Care

  PRINCIPAL INVESTIGATOR

• Reino pöyhiä, MD,PhD

  Helsinki University Central Hospital,Department of Anesthesiology and Intensive Care

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: May 6, 2011
• First Posted: May 9, 2011
• Study Start: September 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: July 6, 2012

Record last verified: 2012-07

Locations

FI (1)