Trial of New Pretreatment Method in Transnasal Endoscopy

Not Applicable

Completed

• Conditions: Pretreatment Method of Transnasal Endoscopy
• Interventions: Procedure: pretreatment method for transnasal endoscopy

• Registration Number: NCT01708967
• Lead Sponsor: Chuncheon Sacred Heart Hospital

Brief Summary

This study designed for compare efficacy of following two anesthetic method for transnasal endoscopy

* "Catheter-free method"

* "Catheter-insertion method"

Detailed Description

1. Check of the medical history (both method)

1. underlying systemic disease

2. drug allergy

3. anticoagulant or antiplatelet use

2. Premedication (both method)

1. taking premedication contain dimethylpolysiloxane, pronase, sodium bicarbonate for improved endoscopic visualization

2. spraying naphazolin acetate into nasal cavity for decrease secretion

3. Different anesthetic method for transnasal endoscopy

1. "Catheter-free method" : spraying epinephrine into nasal cavity

2. "Catheter-insertion method" : spraying both epinephrine and lidocaine into nasal cavity

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Study First Submitted: 2012-10-16
• Study First Submitted QC: 2012-10-16
• Study First Posted: 2012-10-17
• Results First Submitted: 2013-11-09
• Status Verified: 2014-01
• Results First Submitted QC: 2014-01-29
• Last Update Submitted: 2014-01-29
• Results First Posted: 2014-03-13
• Last Update Posted: 2014-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Routine check-up patients

Exclusion Criteria

• nasal operation, an allergy, a possibility of hemorrhage

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Catheter-free method	pretreatment method for transnasal endoscopy	We explored success rate, side effects, and vital signs in patients with catether-free method. Intervention: one-time spray of epinephrine (1cc) plus 4% lidocaine (4cc)
Catheter insertion method	pretreatment method for transnasal endoscopy	We explored success rate, side effects, and vital signs in patients with catether insertion method : use both spray and catheter

Primary Outcome Measures

Name	Time	Method
Success Rate of Transnasal Endoscopy	During transnasal endoscopy, up to 1 hours	We difine the success of transnasal endoscopy as follows: the pateint underwent transnasal endoscopy without signicant complaint nor side effects.; We difine the failure of transnasal endoscopy as follows: the patient cannot tolerate insertion of the endoscope; the patient presents side effects such as epistaxis, pain, or a decrease in O2 saturation; and the endoscope cannot pass through the nasal or oral cavity.

Secondary Outcome Measures

Name	Time	Method
Vital Signs	before, during, and after transnasal endoscopy	Blood pressure, heart rate, and O2 saturation were assessed.

Trial Locations

Locations (1)

Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital; 🇰🇷 Chuncheon, Korea, Republic of