Methods of Nasal Anesthesia Before Transnasal EndoscopyNCT01785173
Endoscopic-guided Versus Cotton-tipped Applicator Gauze Pledgetting for Nasal Anesthesia Before Transnasal Endoscopy
A study testing Endoscopic-guided gauze pledgetting and Cotton-tipped applicator gauze pledgetting in people with Methods of Nasal Anesthesia Before Transnasal Endoscopy and Side Effects of Transnasal Endoscopy, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
Trial summary
Unsedated transnasal esophago-gastro-duodenoscopy (UT-EGD) has gained wide popularity and is one of the most frequently performed diagnostic procedures in Japan and Europe. The technique of using a cotton pledget soaked with lignocaine and decongestant is quite effective but does cause some discomfort during… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Methods of Nasal Anesthesia Before Transnasal Endoscopy, Side Effects of Transnasal Endoscopy, Patient's Tolerance to Transnasal Endoscopy
- What is being tested?
- Endoscopic-guided gauze pledgetting and Cotton-tipped applicator gauze pledgetting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2012to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All outpatients with epigastric discomfort (non-ulcer dyspepsia),
- aged 18-65 years are eligibility for this study.
Who cannot join
- Patients who can not answer questionnaires,
- who have prior nasal trauma or surgery, recent or present upper gastrointestinal bleeding and coagulopathy are excluded from this study.
- Patients who are allergic to lidocaine and who have uncontrolled hypertension or coronary artery disease are not recruited.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Buddhist Tzu Chi Hospital
Hualien City, Hualien county, 970
Chi-Tan Hu, MD, PhD, +886933995773, chitan.hu@msa.hinet.net
About this study
Official title: A Randomized Study Comparing Endoscopic-guided Gauze Pledgetting and Cotton-tipped Applicator Packing for Nasal Anesthesia Before Transnasal Endoscopy
Unsedated transnasal esophago-gastro-duodenoscopy (UT-EGD) has gained wide popularity and is one of the most frequently performed diagnostic procedures in Japan and Europe. The technique of using a cotton pledget soaked with lignocaine and decongestant is quite effective but does cause some discomfort during application of anesthetic agent to the nasal cavity. Hence, an effective method to deliver anesthetic agent, using a minimal dose of drugs, and at the same time maintain a good field of vision during endoscopy are all very important.
Using a cotton-tippled applicator to deliver a soaked gauze strip may cause kinking of it around the nasal vestibule or just in the anterior end of a turbinate. Endoscopic guidance to deliver a gauze strip can confirm delivering it to at least the posterior end of a turbinate. We hypothesize that a simple endoscopic-guided gauze pledgetting method is more tolerable than the "blind" cotton-tippled applicator method to deliver a gauze strip for anesthetizing the nasal cavity.
Read the detailed description
Nasal anesthesia is the rate-limiting step for a well tolerable unsedated transnasal esophago-gastro-duodenoscopy (UT-EGD) procedure. The technique of using a cotton pledget soaked with lignocaine and decongestant is quite effective but does cause some discomfort during application of a cotton pledget to the nasal cavity. Hence, an effective method to deliver anesthetic agent and maintain a good field of vision during endoscopy are all very important.
Using a cotton-tippled applicator to deliver a soaked gauze strip may cause kinking of it around the nasal vestibule or just in the anterior end of a turbinate. Endoscopic guidance to deliver a gauze strip can confirm delivering it to at least the posterior end of a turbinate. We propose that a simple Endoscopic-Guided Gauze Pledgetting method (EGGP) is more tolerable than the "blind" cotton-tippled applicator method to deliver a gauze strip for anesthetizing the nasal cavity.
We hypothesize that this method can deliver a gauze strip to the superior end of a turbinate, thus inducing more adequate nasal anesthesia and reducing nasal pain. Hence, the primary objective of this study was to evaluate whether this EGGP method could reduce side effects such as nasal pain and bleeding and improve tolerance associated with UT-EGD. In a large tertiary referral hospital in Taiwan, We are going to conduct a prospective randomized-controlled trial to compare patient tolerance, safety and adverse events between EGGP versus cotton-tipped applicator primed gauze pledgetting (CTGP) methods of nasal anesthesia.
- Conditions
- Methods of Nasal Anesthesia Before Transnasal Endoscopy, Side Effects of Transnasal Endoscopy, Patient's Tolerance to Transnasal Endoscopy
- Being tested
- Endoscopic-guided gauze pledgetting, Cotton-tipped applicator gauze pledgetting
- Keywords
- Endoscopes, Esophago-gastro-duodenoscopy, Transnasal endoscopy, Nasal anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic-guided gauze pledgettingProcedure or surgery
By using a transnasal endoscope as a guide and a biopsy forceps, a gauze strip soaked with decongestant and anesthesia will be delivered to a selected nasal meatus chosen by anterior rhinoscopy.
Cotton-tipped applicator gauze pledgettingProcedure or surgery
In contrast to the endoscopic-guided, forceps-delivering method, a gauze strip is delivered to a selected meatus by a cotton-tipped applicator.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic-guided gauze pledgetting | Experimental | All patients in the study group receive endoscopic-guided gauze pledgetting (EGGP) nasal anesthesia. Each patient will receive an anterior rhinoscopy to select the most patent meatus for gauze pledegetting by a validated meatus scoring scale. The endoscope is preloaded with a 1.8 mm biopsy forceps to pick up the acute angle between the shorter leg and hypotenuse of a right-angled gauze strip (already soaked with anesthesia/decongestant) and retract back just into the biopsy channel. When the transnasal endoscope tip is set in the nasal vestibule, the preloaded biopsy forceps is protruded slowly into the desired meatus under endoscope monitoring. A gauze strip is at least brought onto the posterior end of the inferior or middle turbinate. Receives: Procedure: Endoscopic-guided gauze pledgetting |
| Cotton-tipped applicator pledgetting | Active comparator | Another randomized group of patients will receive cotton-tipped applicator gauze pledgetting (CTGP) method of nasal anesthesia. Two cotton-tippled applicators help determine the following: (a) right or left side, (b) inferior or middle nasal meatus (INM or MNM) and (c) the need of local epinephrine. The investigators apply gently in parallel two sterile 3" x 1/10", double-ended, plastic shaft cotton-tipped applicators, pretreated with minimal amount of 2% viscous lidocaine plus 4% liquid lidocaine, to lubricate and anesthetize the more patent meatus One cotton-tipped applicator is re-used to deliver a triangular gauze strip to the selected meatus during the gauze pledgetting procedure. Receives: Procedure: Cotton-tipped applicator gauze pledgetting |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measures are tolerability profiles on a validated visual analogue scale
The primary outcome measures are tolerability profiles on a validated visual analogue scale (VAS) and difficulty in inserting the transnasal endoscope through a selected meatus based on a Likert scale. The Likert scale has 5 points of difficulty: minimal, slight, moderate, substantial, and extreme. Facing a 5-point VAS card (1 = minimal discomfort to 5 = severe discomfort), all patients give real-time feedback immediately after UT-EGD by speaking or pointing out their scorings for the following: (1) pain during anesthesia, (2) pain during nasal insertions, (3) pain during exsertion, and (4) overall tolerance.
Measured: Immediately after transnasal endoscopy up to all questionnaires answered (about 15 minutes)
Secondary outcomes (1)
Secondary outcome measures evaluate the side effects of nasal anesthesia
Secondary outcome measures will be evaluated by assisting nurses, who record
(a) immediate responses including: (i) epistaxis, (ii) immediately post-procedural side effects including headache, light headiness, and mucous discharge, and (iii) patient's willingness to receive the same procedure the next time, and (b) delayed side effect including (i) persisting nasal discharge, (ii) epistaxis 24 hours after UT-EGD, and (iii) sinusitis all confirmed by otolaryngologists within two weeks after UT-EGD. The visual capacity for the anterior nasal cavity ranking on a 5-point scale (5 represented standard EGD and 1 poor visual quality) is also evaluated by assisting nurses during endoscopic insertion after nasal decongestive anesthesia.
Measured: The immediate secondary outcome measures will be evaluated by questionnaires immediately after UT-EGD and the delayed secondary outcome measures will be evaluated by otolaryngologists within two weeks after UT-EGD.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startOct 2012
- Primary completionApr 2013 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methods of Nasal Anesthesia Before 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chi-Tan Hu, Buddhist Tzu Chi General Hospital
- Investigators
- Chi-Tan Hu, MD, PhD, Principal investigator, Budhist Tzu Chi Hospital and Tzu Chi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01785173
- Sponsor's protocol ID
- IRB101-85
- Status last verified
- Feb 2013
- First submitted
- 5 Feb 2013
- Last updated
- 7 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study Comparing Endoscopic-guided Gauze Pledgetting and Cotton-tipped Applicator Packing for Nasal Anesthesia Before Transnasal Endoscopy
- ClinicalTrials.gov ID
- NCT01785173
- Acronym / sponsor ID
- IRB101-85
- Conditions
- Methods of Nasal Anesthesia Before Transnasal Endoscopy, Side Effects of Transnasal Endoscopy, Patient's Tolerance to Transnasal Endoscopy
- Keywords
- Endoscopes, Esophago-gastro-duodenoscopy, Transnasal endoscopy, Nasal anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 7 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Unsedated transnasal esophago-gastro-duodenoscopy (UT-EGD) has gained wide popularity and is one of the most frequently performed diagnostic procedures in Japan and Europe. The technique of using a cotton pledget soaked with lignocaine and decongestant is quite effective but does cause some discomfort during application of anesthetic agent to the nasal cavity. Hence, an effective method to deliver anesthetic agent, using a minimal dose of drugs, and at the same time maintain a good field of vision during endoscopy are all very important.
Using a cotton-tippled applicator to deliver a soaked gauze strip may cause kinking of it around the nasal vestibule or just in the anterior end of a turbinate. Endoscopic guidance to deliver a gauze strip can confirm delivering it to at least the posterior end of a turbinate. We hypothesize that a simple endoscopic-guided gauze pledgetting method is more tolerable than the "blind" cotton-tippled applicator method to deliver a gauze strip for anesthetizing the nasal cavity.
Detailed description
Nasal anesthesia is the rate-limiting step for a well tolerable unsedated transnasal esophago-gastro-duodenoscopy (UT-EGD) procedure. The technique of using a cotton pledget soaked with lignocaine and decongestant is quite effective but does cause some discomfort during application of a cotton pledget to the nasal cavity. Hence, an effective method to deliver anesthetic agent and maintain a good field of vision during endoscopy are all very important.
Using a cotton-tippled applicator to deliver a soaked gauze strip may cause kinking of it around the nasal vestibule or just in the anterior end of a turbinate. Endoscopic guidance to deliver a gauze strip can confirm delivering it to at least the posterior end of a turbinate. We propose that a simple Endoscopic-Guided Gauze Pledgetting method (EGGP) is more tolerable than the "blind" cotton-tippled applicator method to deliver a gauze strip for anesthetizing the nasal cavity.
We hypothesize that this method can deliver a gauze strip to the superior end of a turbinate, thus inducing more adequate nasal anesthesia and reducing nasal pain. Hence, the primary objective of this study was to evaluate whether this EGGP method could reduce side effects such as nasal pain and bleeding and improve tolerance associated with UT-EGD. In a large tertiary referral hospital in Taiwan, We are going to conduct a prospective randomized-controlled trial to compare patient tolerance, safety and adverse events between EGGP versus cotton-tipped applicator primed gauze pledgetting (CTGP) methods of nasal anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic-guided gauze pledgetting | Experimental | Procedure: Endoscopic-guided gauze pledgettingAll patients in the study group receive endoscopic-guided gauze pledgetting (EGGP) nasal anesthesia. Each patient will receive an anterior rhinoscopy to select the most patent meatus for gauze pledegetting by a validated meatus scoring scale. The endoscope is preloaded with a 1.8 mm biopsy forceps to pick up the acute angle between the shorter leg and hypotenuse of a right-angled gauze strip (already soaked with anesthesia/decongestant) and retract back just into the biopsy channel. When the transnasal endoscope tip is set in the nasal vestibule, the preloaded biopsy forceps is protruded slowly into the desired meatus under endoscope monitoring. A gauze strip is at least brought onto the posterior end of the inferior or middle turbinate. |
| Cotton-tipped applicator pledgetting | Active comparator | Procedure: Cotton-tipped applicator gauze pledgettingAnother randomized group of patients will receive cotton-tipped applicator gauze pledgetting (CTGP) method of nasal anesthesia. Two cotton-tippled applicators help determine the following: (a) right or left side, (b) inferior or middle nasal meatus (INM or MNM) and (c) the need of local epinephrine. The investigators apply gently in parallel two sterile 3" x 1/10", double-ended, plastic shaft cotton-tipped applicators, pretreated with minimal amount of 2% viscous lidocaine plus 4% liquid lidocaine, to lubricate and anesthetize the more patent meatus One cotton-tipped applicator is re-used to deliver a triangular gauze strip to the selected meatus during the gauze pledgetting procedure. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All outpatients with epigastric discomfort (non-ulcer dyspepsia),
- aged 18-65 years are eligibility for this study.
Key exclusion criteria (3 listed)
- Patients who can not answer questionnaires,
- who have prior nasal trauma or surgery, recent or present upper gastrointestinal bleeding and coagulopathy are excluded from this study.
- Patients who are allergic to lidocaine and who have uncontrolled hypertension or coronary artery disease are not recruited.
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 |
|---|---|---|
| Endoscopic-guided gauze pledgettingBy using a transnasal endoscope as a guide and a biopsy forceps, a gauze strip soaked with decongestant and anesthesia will be delivered to a selected nasal meatus chosen by anterior rhinoscopy. | Procedure or surgery | Endoscopic-guided gauze pledgetting |
| Cotton-tipped applicator gauze pledgettingIn contrast to the endoscopic-guided, forceps-delivering method, a gauze strip is delivered to a selected meatus by a cotton-tipped applicator. | Procedure or surgery | Cotton-tipped applicator pledgetting |
Primary outcome
The primary outcome measures are tolerability profiles on a validated visual analogue scale
Time frame: Immediately after transnasal endoscopy up to all questionnaires answered (about 15 minutes)
The primary outcome measures are tolerability profiles on a validated visual analogue scale (VAS) and difficulty in inserting the transnasal endoscope through a selected meatus based on a Likert scale. The Likert scale has 5 points of difficulty: minimal, slight, moderate, substantial, and extreme. Facing a 5-point VAS card (1 = minimal discomfort to 5 = severe discomfort), all patients give real-time feedback immediately after UT-EGD by speaking or pointing out their scorings for the following: (1) pain during anesthesia, (2) pain during nasal insertions, (3) pain during exsertion, and (4) overall tolerance.
1 secondary outcome
Secondary outcome measures evaluate the side effects of nasal anesthesia
Time frame: The immediate secondary outcome measures will be evaluated by questionnaires immediately after UT-EGD and the delayed secondary outcome measures will be evaluated by otolaryngologists within two weeks after UT-EGD.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2013.
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.
Chi-Tan Hu, MD, PhD principal investigator
Budhist Tzu Chi Hospital and Tzu Chi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic-guided gauze pledgetting and Cotton-tipped applicator gauze pledgetting in people with Methods of Nasal Anesthesia Before Transnasal Endoscopy and Side Effects of Transnasal Endoscopy, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 Feb 2013. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chi-Tan Hu, MD, PhD (+886933995773, chitan.hu@msa.hinet.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measures are tolerability profiles on a validated visual analogue scale (time frame: Immediately after transnasal endoscopy up to all questionnaires answered (about 15 minutes)). 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 7 Feb 2013.