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This study designed for compare efficacy of following two anesthetic method for transnasal endoscopy
Check of the medical history (both method)
Premedication (both method)
Different anesthetic method for transnasal endoscopy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Catheter-free method | Experimental | 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) |
|
| Catheter insertion method | Experimental | We explored success rate, side effects, and vital signs in patients with catether insertion method : use both spray and catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pretreatment method for transnasal endoscopy | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Vital Signs | Blood pressure, heart rate, and O2 saturation were assessed. | before, during, and after transnasal endoscopy |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ki Tae Suk, M.D.,Ph.D. | Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital | Chuncheon | 200-704 | South Korea |
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| ID | Title | Description |
|---|---|---|
| FG000 | Catheter-free Method | We explored success rate, side effects, and vital signs in patients with one-time spray method. Intervention: one-time spray of epinephrine (1cc) plus 4% lidocaine (4cc) pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected. spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected. |
| FG001 | Catheter-insertion Method | We explored success rate, side effects, and vital signs in patients with spray+catheter method. Intervention: use both spray and catheter pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected. spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Catheter-free Method | We explored success rate, side effects, and vital signs in patients with one-time spray method. Intervention: one-time spray of epinephrine (1cc) plus 4% lidocaine (4cc) |
| BG001 | Catheter-insertion Method |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Vital Signs | Blood pressure, heart rate, and O2 saturation were assessed. | Not Posted | before, during, and after transnasal endoscopy | ||||||||||||
| Other Pre-specified | 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. | Not Posted | after transnasal endoscopy |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Catheter-free Method | We explored success rate, side effects, and vital signs in patients with one-time spray method. Intervention: one-time spray of epinephrine (1cc) plus 4% lidocaine (4cc) pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected. spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected. |
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A limitation of this study was the small number of patients; n = 93 is insufficient to conclusively generalize the efficiency of the catheter-free method.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ki Tae Suk | Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea | +82-33-240-5826 | ktsuk@hallym.ac.kr |
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We explored success rate, side effects, and vital signs in patients with spray+catheter method.
Intervention: use both spray and catheter
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | 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. | Posted | Number | 95% Confidence Interval | percentage of Participants | During transnasal endoscopy, up to 1 hours |
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| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Catheter-insertion Method | We explored success rate, side effects, and vital signs in patients with spray+catheter method. Intervention: use both spray and catheter pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected. spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected. | 0 | 43 | 0 | 43 |
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