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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-011618-12 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsiki University Central Hospital,Meilahti Hospital,Endoscopy unit | Helsinki | Uusimaa | 00029 | Finland |
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| ID | Term |
|---|---|
| D002355 | Carticaine |
| D012965 | Sodium Chloride |
| D007267 | Injections |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| 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. |
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The easiness of gastroscopy performance will be evaluated by endoscopists' with structured questionnaire. |
| one day |
| D006571 |
| Heterocyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |