Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, 200-704, South Korea
Completed
NCT Number: NCT01708967
Trial of New Pretreatment Method in Transnasal Endoscopy
This study designed for compare efficacy of following two anesthetic method for transnasal endoscopy
* "Catheter-free method" * "Catheter-insertion method"
Completed
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Conditions
Age range
20 year–90 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
- 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
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Routine check-up patients
Exclusion criteria
- nasal operation, an allergy, a possibility of hemorrhage
Treatment and study plan
pretreatment method for transnasal endoscopy
ProcedureCatheter-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
Primary outcomes
-
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.
Secondary outcomes
-
Vital Signs
Time frame: before, during, and after transnasal endoscopy
Blood pressure, heart rate, and O2 saturation were assessed.
Other outcomes
-
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.
Sponsors and collaborators
Lead sponsor
Chuncheon Sacred Heart Hospital
Other
Registry information
Official study title
One-time Spray of Epinephrine (1cc) Plus 4% Lidocaine (4cc) is Sufficient Pretreatment Method for the Preparation of Transnasal Endoscopy
Acronym: RTNPMTNE
Important dates
- Study start
- 2009
- Primary completion
- 2009
- Study completion
- 2009
- First posted
- Oct 17, 2012
- Registry last updated
- Mar 13, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.