Pretreatment Method of Transnasal EndoscopyRTNPMTNENCT01708967
Trial of New Pretreatment Method in Transnasal Endoscopy
A study testing pretreatment method for transnasal endoscopy in people with Pretreatment Method of Transnasal Endoscopy, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.
Trial summary
This study designed for compare efficacy of following two anesthetic method for transnasal endoscopy "Catheter-free method" "Catheter-insertion method" Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Pretreatment Method of Transnasal Endoscopy
- What is being tested?
- pretreatment method for transnasal endoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2009to Aug 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Routine check-up patients
Who cannot join
- nasal operation, an allergy, a possibility of hemorrhage
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, 200-704
About this study
Official title: One-time Spray of Epinephrine (1cc) Plus 4% Lidocaine (4cc) is Sufficient Pretreatment Method for the Preparation of Transnasal Endoscopy
This study designed for compare efficacy of following two anesthetic method for transnasal endoscopy
- "Catheter-free method"
- "Catheter-insertion method"
Read the detailed description
- 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
- Being tested
- pretreatment method for transnasal endoscopy
- Keywords
- transnasal endoscopy, pretreatment method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pretreatment method for transnasal endoscopyProcedure or surgery
Also called Catheter-free method/Cathter insertion method
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Procedure: pretreatment method for transnasal endoscopy |
| Catheter insertion method | Experimental | We explored success rate, side effects, and vital signs in patients with catether insertion method : use both spray and catheter Receives: Procedure: pretreatment method for transnasal endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During transnasal endoscopy, up to 1 hours
Secondary outcomes (1)
Vital Signs
Blood pressure, heart rate, and O2 saturation were assessed.
Measured: before, during, and after transnasal endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2012 (estimated)
- Study startMar 2009
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pretreatment Method of Transnasal EndoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chuncheon Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ki Tae Suk, Chuncheon Sacred Heart Hospital
- Investigators
- Ki Tae Suk, M.D.,Ph.D., Principal investigator, Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01708967
- Sponsor's protocol ID
- OTSMVSSCM
- Acronym
- RTNPMTNE
- Status last verified
- Jan 2014
- First submitted
- 16 Oct 2012
- Last updated
- 13 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-time Spray of Epinephrine (1cc) Plus 4% Lidocaine (4cc) is Sufficient Pretreatment Method for the Preparation of Transnasal Endoscopy
- ClinicalTrials.gov ID
- NCT01708967
- Acronym / sponsor ID
- RTNPMTNE / OTSMVSSCM
- Keywords
- transnasal endoscopy, pretreatment method
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Chuncheon Sacred Heart HospitalUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 17 Oct 2012 (estimated)
- Results
- Posted 13 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study designed for compare efficacy of following two anesthetic method for transnasal endoscopy
- "Catheter-free method"
- "Catheter-insertion method"
Detailed description
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Catheter-free method | Experimental | Procedure: pretreatment method for transnasal endoscopyWe 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 | Procedure: pretreatment method for transnasal endoscopyWe explored success rate, side effects, and vital signs in patients with catether insertion method : use both spray and catheter |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Routine check-up patients
Key exclusion criteria (1 listed)
- nasal operation, an allergy, a possibility of hemorrhage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pretreatment method for transnasal endoscopyAlso: Catheter-free method/Cathter insertion methodCatheter-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. | Procedure or surgery | Catheter insertion method, Catheter-free method |
Primary outcome
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.
1 secondary outcome
Vital Signs
Time frame: before, during, and after transnasal endoscopy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ki Tae Suk, M.D.,Ph.D. principal investigator
Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pretreatment method for transnasal endoscopy in people with Pretreatment Method of Transnasal Endoscopy, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success Rate of Transnasal Endoscopy (time frame: During transnasal endoscopy, up to 1 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2014.