Trial of New Pretreatment Method in Transnasal Endoscopy

Study Overview
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Brief Summary
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This study designed for compare efficacy of following two anesthetic method for transnasal endoscopy Catheter-free method Catheter-insertion method

Detailed Description
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Check of the medical history (both method) underlying systemic disease drug allergy anticoagulant or antiplatelet use Premedication (both method) taking premedication contain dimethylpolysiloxane, pronase, sodium bicarbonate for improved endoscopic visualization spraying naphazolin acetate into nasal cavity for decrease secretion Different anesthetic method for transnasal endoscopy Catheter-free method : spraying epinephrine into nasal cavity Catheter-insertion method : spraying both epinephrine and lidocaine into nasal cavity

Official Title
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One-time Spray of Epinephrine (1cc) Plus 4% Lidocaine (4cc) is Sufficient Pretreatment Method for the Preparation of Transnasal Endoscopy

Conditions
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Pretreatment Method of Transnasal Endoscopy

Intervention / Treatment
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* Procedure: pretreatment method for transnasal endoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Routine check-up patients Exclusion Criteria: nasal operation, an allergy, a possibility of hemorrhage

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Catheter-free method<br>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) | Procedure: pretreatment method for transnasal endoscopy<br>* Catheter-free method : The patient then takes simethicone (10cc). After that, the nasal cavity is sprayed with epinephrine (1cc) and lidocaine HCL (4%, 4cc). Catheter inesertion method: After preparation steps the same as in the 'catheter-free' method, a 14 Fr. flexible catheter is coated with 2% lidocaine HCL gel and 8% lidocaine HCL spray. After that, the catheter is inserted into the patient's nasal cavity, and maintained about 1 minute for anesthesia. A 16 Fr. catheter is prepared by the same method with as the 14Fr. catheter. After the 14 Fr. cathter has been removed from the patient's nasal cavity, the 16 Fr. catheter is inserted into the patient's nasal cavity.<br>* Other names: Catheter-free method/Cathter insertion method;|
| Experimental: Catheter insertion method<br>We explored success rate, side effects, and vital signs in patients with catether insertion method : use both spray and catheter | Procedure: pretreatment method for transnasal endoscopy<br>* Catheter-free method : The patient then takes simethicone (10cc). After that, the nasal cavity is sprayed with epinephrine (1cc) and lidocaine HCL (4%, 4cc). Catheter inesertion method: After preparation steps the same as in the 'catheter-free' method, a 14 Fr. flexible catheter is coated with 2% lidocaine HCL gel and 8% lidocaine HCL spray. After that, the catheter is inserted into the patient's nasal cavity, and maintained about 1 minute for anesthesia. A 16 Fr. catheter is prepared by the same method with as the 14Fr. catheter. After the 14 Fr. cathter has been removed from the patient's nasal cavity, the 16 Fr. catheter is inserted into the patient's nasal cavity.<br>* Other names: Catheter-free method/Cathter insertion method;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success Rate of Transnasal Endoscopy | 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. | During transnasal endoscopy, up to 1 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital Signs | Blood pressure, heart rate, and O2 saturation were assessed. | before, during, and after transnasal endoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transnasal endoscopy, pretreatment method