Trial of New Pretreatment Method in Transnasal Endoscopy (RTNPMTNE)

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

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

• "Catheter-free method"
• "Catheter-insertion method"

Study Overview

• Status: Completed
• Conditions: Pretreatment Method of Transnasal Endoscopy
• Intervention / Treatment: Procedure: pretreatment method for transnasal endoscopy

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Chuncheon, Korea, Republic of, 200-704
    • Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Routine check-up patients

Exclusion Criteria:

• nasal operation, an allergy, a possibility of hemorrhage

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Catheter-free method; 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; 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.; Other Names: Catheter-free method/Cathter insertion method
EXPERIMENTAL: Catheter insertion method; 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; 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.; Other Names: Catheter-free method/Cathter insertion method

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction	Patients were asked to score how well they felt during endoscopy using a visual analog scale; they were also asked whether they would accept one-time spray method or spray+catheter method in the future if necessary.	after transnasal endoscopy

Collaborators and Investigators

• Sponsor: Chuncheon Sacred Heart Hospital
• Investigators: Principal Investigator: Ki Tae Suk, M.D.,Ph.D., Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (ACTUAL): August 1, 2009
• Study Completion (ACTUAL): August 1, 2009

Study Registration Dates

• First Submitted: October 16, 2012
• First Submitted That Met QC Criteria: October 16, 2012
• First Posted (ESTIMATE): October 17, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): March 13, 2014
• Last Update Submitted That Met QC Criteria: January 29, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: transnasal endoscopy; pretreatment method
• Other Study ID Numbers: OTSMVSSCM