Pretreatment Method of Transnasal Endoscopy
Conditions
Keywords
transnasal endoscopy, pretreatment method
Brief summary
This study designed for compare efficacy of following two anesthetic method for transnasal endoscopy * Catheter-free method * Catheter-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
Interventions
PROCEDUREpretreatment 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.
Sponsors
Chuncheon Sacred Heart Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Routine check-up patients
Exclusion criteria
* nasal operation, an allergy, a possibility of hemorrhage
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success Rate of Transnasal Endoscopy | 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
| Measure | Time frame | Description |
|---|---|---|
| Vital Signs | before, during, and after transnasal endoscopy | Blood pressure, heart rate, and O2 saturation were assessed. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction | 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. |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 50 |
| Catheter-insertion Method We explored success rate, side effects, and vital signs in patients with spray+catheter method.
Intervention: use both spray and catheter | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Catheter-insertion Method | Catheter-free Method | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 11 Participants | 24 Participants |
| Age, Categorical Between 18 and 65 years | 37 Participants | 39 Participants | 76 Participants |
| Age, Continuous | 59.7 years STANDARD_DEVIATION 12.3 | 58.4 years STANDARD_DEVIATION 10.8 | 59.00 years STANDARD_DEVIATION 11.5 |
| Region of Enrollment Korea, Republic of | 50 participants | 50 participants | 100 participants |
| Sex: Female, Male Female | 27 Participants | 25 Participants | 52 Participants |
| Sex: Female, Male Male | 23 Participants | 25 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 50 | 0 / 43 |
| serious Total, serious adverse events | 0 / 50 | 0 / 43 |
Outcome results
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.
Time frame: During transnasal endoscopy, up to 1 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Catheter-free Method | Success Rate of Transnasal Endoscopy | 88 percentage of Participants |
| Catheter-insertion Method | Success Rate of Transnasal Endoscopy | 88 percentage of Participants |
Secondary
Vital Signs
Blood pressure, heart rate, and O2 saturation were assessed.
Time frame: 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.
Time frame: after transnasal endoscopy