Trial of New Pretreatment Method in Transnasal Endoscopy (RTNPMTNE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ki Tae Suk, Chuncheon Sacred Heart Hospital
ClinicalTrials.gov Identifier:
NCT01708967
First received: October 16, 2012
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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

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

Condition Intervention
Pretreatment Method of Transnasal Endoscopy
Procedure: pretreatment method for transnasal endoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: One-time Spray of Epinephrine (1cc) Plus 4% Lidocaine (4cc) is Sufficient Pretreatment Method for the Preparation of Transnasal Endoscopy

Resource links provided by NLM:


Further study details as provided by Chuncheon Sacred Heart Hospital:

Primary Outcome Measures:
  • Success Rate of Transnasal Endoscopy [ Time Frame: During transnasal endoscopy, up to 1 hours ] [ Designated as safety issue: Yes ]

    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:
  • Vital Signs [ Time Frame: before, during, and after transnasal endoscopy ] [ Designated as safety issue: Yes ]
    Blood pressure, heart rate, and O2 saturation were assessed.


Other Outcome Measures:
  • Satisfaction [ Time Frame: after transnasal endoscopy ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 100
Study Start Date: March 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Catheter-free method/Cathter 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
  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Routine check-up patients

Exclusion Criteria:

  • nasal operation, an allergy, a possibility of hemorrhage
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01708967

Locations
Korea, Republic of
Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, Korea, Republic of, 200-704
Sponsors and Collaborators
Chuncheon Sacred Heart Hospital
Investigators
Principal Investigator: Ki Tae Suk, M.D.,Ph.D. Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital
  More Information

No publications provided

Responsible Party: Ki Tae Suk, doctor, assistant professor, Chuncheon Sacred Heart Hospital
ClinicalTrials.gov Identifier: NCT01708967     History of Changes
Other Study ID Numbers: OTSMVSSCM
Study First Received: October 16, 2012
Results First Received: November 9, 2013
Last Updated: January 29, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Chuncheon Sacred Heart Hospital:
transnasal endoscopy
pretreatment method

Additional relevant MeSH terms:
Epinephrine
Lidocaine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Mydriatics
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sensory System Agents
Sodium Channel Blockers
Sympathomimetics
Therapeutic Uses
Vasoconstrictor Agents
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on October 21, 2014