Trial of New Pretreatment Method in Transnasal Endoscopy

NCT ID: NCT01708967

Last Updated: 2014-03-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-08-31

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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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

Conditions

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Pretreatment Method of Transnasal Endoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

pretreatment method for transnasal endoscopy

Intervention Type PROCEDURE

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.

Catheter insertion method

We explored success rate, side effects, and vital signs in patients with catether insertion method : use both spray and catheter

Group Type EXPERIMENTAL

pretreatment method for transnasal endoscopy

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Catheter-free method/Cathter insertion method

Eligibility Criteria

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Inclusion Criteria

* Routine check-up patients

Exclusion Criteria

* nasal operation, an allergy, a possibility of hemorrhage
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chuncheon Sacred Heart Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ki Tae Suk

doctor, assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ki Tae Suk, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital

Locations

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Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital

Chuncheon, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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OTSMVSSCM

Identifier Type: -

Identifier Source: org_study_id

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