Trial of New Pretreatment Method in Transnasal Endoscopy (RTNPMTNE)

January 29, 2014 updated by: Ki Tae Suk, Chuncheon Sacred Heart Hospital

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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.
During transnasal endoscopy, up to 1 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vital Signs
Time Frame: before, during, and after transnasal endoscopy
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
Time Frame: after transnasal endoscopy
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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • OTSMVSSCM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe