Throat superficial anaesthesia with articaine during investigation of the oesophagus and stomach with illuminated fiberoptic flexible tubular instrument

• Conditions: Patients who undergo esophagogastroduodenoscopy procedure for a first time; MedDRA version: 17.0Level: PTClassification code 10014819Term: Endoscopy upper gastrointestinal tractSystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2012-005528-13-FI
• Lead Sponsor: Helsinki University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-16
• Last Update Posted: 30 June 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-elective procedure
-weight over 40 kg
-American Society of Anesthesiology class I-III
-first upper GI endoscopy procedure
-finnish or/and swedish
speaking
- age 20-75
- both gender
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

-amide and/or esther local anaesthetic allergy
-paraben allergy
-Child-Pugh grade B/C liver failure
-renal insufficiency (calculated glomerular filtration rate under 60 ml/min/1.73 m2 according to Cockcroft-Gault scale )
-dementia
-those presenting with swallowing problem
-chronic pain condition
-chronic use of pain medication
-pregnancy
-lactation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified