AnesthesiaNCT01886768
Double Versus Single Pledget Nasal Anesthesia for Transnasal Endoscopy
A study testing Double pledget nasal anesthesia (DPNA) and Single pledget nasal anesthesia (SPNA) in people with Anesthesia and Epistaxis, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
Trial summary
Unsedated ultrathin transnasal esophago-gastro-duodenoscopy (UT-EGD), in comparison with conventional peroral EGD (P-EGD) has been shown to be more tolerable, safer, cost-effective and time-efficient. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia, Epistaxis
- What is being tested?
- Double pledget nasal anesthesia (DPNA) and Single pledget nasal anesthesia (SPNA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2012to Feb 2014
- 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: Double Versus Single Pledget Method of Nasal Anesthesia for Transnasal Endoscopy: A Randomized Prospective Control Study
Unsedated ultrathin transnasal esophago-gastro-duodenoscopy (UT-EGD), in comparison with conventional peroral EGD (P-EGD) has been shown to be more tolerable, safer, cost-effective and time-efficient. The investigators and in other studies have showed that nasal pledgetting (or commonly termed nasal packing) is better than nasal spray in terms of patient tolerance and visual capacity. Although pledgetting method to a selected meatus can achieve better decongestion effect, epistaxis and nasal pain in some patients are still frustrating to endoscopists.
The investigator has proposed a novel meatus scoring scale to evaluate nasal insertability by anterior rhinoscopy using a transnasal endoscope. The investigator also suggest endoscopic-guided gauze pledgetting can provide precise nasal anesthesia, thereby reducing trauma/bleeding in the nasal cavity and increasing patient tolerance during transnasal endoscopy. Endoscopic guidance to deliver a gauze strip can confirm delivering it to at least the posterior end of a turbinate. We hypothesize that by using endoscopic-guided method, gauze pledgetting to both the inferior nasal meatus (INM) and middle nasal meatus (MNM) simultaneously is more tolerable than only gauze pledgetting to a single meatus.
Read the detailed description
Nasal anesthesia is the rate-limiting step for a well tolerable unsedated transnasal esophago-gastro-duodenoscopy (UT-EGD) procedure. The investigator has proposed 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. The initial idea of EGGP is to anesthetize only one single selected meatus. To compare patient tolerance, safety and adverse events between double pledget (DPNA, i.e. INM and MNM) versus single pledget (SPNA, i.e. INM or MNM) methods of nasal anesthesia, the investigator is going to conduct a prospective randomized-controlled trial. The rationale for using double pledget is threefold: (1) the middle meatus is bounded by the INT and MNT; (2) the inserting and exserting meatuses may be different; (3) erective spongy tissue is mainly distributed in the inferior and middle turbinates and the nasal septum. Therefore, the primary objective of this study is to evaluate whether DPNA is more tolerable and safer than DPNA before UT-EGD.
- Conditions
- Anesthesia, Epistaxis
- Being tested
- Double pledget nasal anesthesia (DPNA), Single pledget nasal anesthesia (SPNA)
- Keywords
- Nasal anesthesia, endoscopes, transnasal endoscopy
- Medical subject headings
- Epistaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double pledget nasal anesthesia (DPNA)Device
Also called A piece of a 10 X 10 cm Kendall gauze square (Eagle Highland Pharmacy,Indiana, USA) is cut into 4 right-angled triangular gauze strips., Two right-angled triangular gauze strip are used in DPNA
By using a transnasal endoscope as a guide and a biopsy forceps, two gauze strips soaked with decongestant and anesthesia will be delivered to the middle meatus followed by the inferior meatus under real-time transnasal endoscopic guidance.
Single pledget nasal anesthesia (SPNA)Device
Also called A piece of a 10 X 10 cm Kendall gauze square (Eagle Highland Pharmacy,Indiana, USA) is cut into 4 right-angled triangular gauze strips., Only one right-angled triangular gauze strip is used in DPNA.
Another randomized group of patients will also receive endoscopic-guided gauze pledgetting using a transnasal endoscope as a guide and a biopsy forceps. One gauze strip soaked with decongestant and anesthesia will be delivered to either the middle meatus or inferior meatus determined by anterior rhinoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Double pledget nasal anesthesia | Experimental | All patients in the double pledget nasal anesthesia group receive endoscopic-guided gauze nasal pledgetting to both the inferior nasal meatus and middle nasal meatus. Each patient will receive an anterior rhinoscopy to select the most patent meatus by a validated meatus scoring scale. The endoscope is preloaded with a 1.8 mm biopsy forceps to pick up a right-angled gauze strip. A preloaded biopsy forceps is protruded slowly into the middle meatus first under endoscope monitoring. The second gauze pledgetting procedure is performed two minutes after the first gauze pledgetting which serves to induce turbinate size reduction to both the INT and MNT. A gauze strip is at least brought onto the posterior end of the inferior or middle turbinate. Receives: Device: Double pledget nasal anesthesia (DPNA) |
| Single pledget nasal anesthesia | Active comparator | All patients in the single pledget nasal anesthesia group receive endoscopic-guided gauze nasal pledgetting to either the inferior nasal meatus or middle nasal meatus determined by anterior rhinoscopy. Each patient will receive an anterior rhinoscopy to select the most patent meatus by a validated meatus scoring scale. The endoscope is preloaded with a 1.8 mm biopsy forceps to pick up a right-angled gauze strip. A gauze strip is at least brought onto the posterior end of the inferior or middle turbinate. Receives: Device: Single pledget nasal anesthesia (SPNA) |
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 within 15 minutes 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 posted26 Jun 2013 (estimated)
- Study startSep 2012
- Primary completionFeb 2014 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- 212 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, Principal investigator, Budhist Tzu Chi Hospital and Tzu Chi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886768
- Sponsor's protocol ID
- IRB101-101
- Status last verified
- Jun 2013
- First submitted
- 7 Feb 2013
- Last updated
- 26 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Versus Single Pledget Method of Nasal Anesthesia for Transnasal Endoscopy: A Randomized Prospective Control Study
- ClinicalTrials.gov ID
- NCT01886768
- Acronym / sponsor ID
- IRB101-101
- Conditions
- Anesthesia, Epistaxis
- Keywords
- Nasal anesthesia, endoscopes, transnasal endoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 26 Jun 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 ultrathin transnasal esophago-gastro-duodenoscopy (UT-EGD), in comparison with conventional peroral EGD (P-EGD) has been shown to be more tolerable, safer, cost-effective and time-efficient. The investigators and in other studies have showed that nasal pledgetting (or commonly termed nasal packing) is better than nasal spray in terms of patient tolerance and visual capacity. Although pledgetting method to a selected meatus can achieve better decongestion effect, epistaxis and nasal pain in some patients are still frustrating to endoscopists.
The investigator has proposed a novel meatus scoring scale to evaluate nasal insertability by anterior rhinoscopy using a transnasal endoscope. The investigator also suggest endoscopic-guided gauze pledgetting can provide precise nasal anesthesia, thereby reducing trauma/bleeding in the nasal cavity and increasing patient tolerance during transnasal endoscopy. Endoscopic guidance to deliver a gauze strip can confirm delivering it to at least the posterior end of a turbinate. We hypothesize that by using endoscopic-guided method, gauze pledgetting to both the inferior nasal meatus (INM) and middle nasal meatus (MNM) simultaneously is more tolerable than only gauze pledgetting to a single meatus.
Detailed description
Nasal anesthesia is the rate-limiting step for a well tolerable unsedated transnasal esophago-gastro-duodenoscopy (UT-EGD) procedure. The investigator has proposed 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. The initial idea of EGGP is to anesthetize only one single selected meatus. To compare patient tolerance, safety and adverse events between double pledget (DPNA, i.e. INM and MNM) versus single pledget (SPNA, i.e. INM or MNM) methods of nasal anesthesia, the investigator is going to conduct a prospective randomized-controlled trial. The rationale for using double pledget is threefold: (1) the middle meatus is bounded by the INT and MNT; (2) the inserting and exserting meatuses may be different; (3) erective spongy tissue is mainly distributed in the inferior and middle turbinates and the nasal septum. Therefore, the primary objective of this study is to evaluate whether DPNA is more tolerable and safer than DPNA before UT-EGD.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Double pledget nasal anesthesia | Experimental | Device: Double pledget nasal anesthesia (DPNA)All patients in the double pledget nasal anesthesia group receive endoscopic-guided gauze nasal pledgetting to both the inferior nasal meatus and middle nasal meatus. Each patient will receive an anterior rhinoscopy to select the most patent meatus by a validated meatus scoring scale. The endoscope is preloaded with a 1.8 mm biopsy forceps to pick up a right-angled gauze strip. A preloaded biopsy forceps is protruded slowly into the middle meatus first under endoscope monitoring. The second gauze pledgetting procedure is performed two minutes after the first gauze pledgetting which serves to induce turbinate size reduction to both the INT and MNT. A gauze strip is at least brought onto the posterior end of the inferior or middle turbinate. |
| Single pledget nasal anesthesia | Active comparator | Device: Single pledget nasal anesthesia (SPNA)All patients in the single pledget nasal anesthesia group receive endoscopic-guided gauze nasal pledgetting to either the inferior nasal meatus or middle nasal meatus determined by anterior rhinoscopy. Each patient will receive an anterior rhinoscopy to select the most patent meatus by a validated meatus scoring scale. The endoscope is preloaded with a 1.8 mm biopsy forceps to pick up a right-angled gauze strip. A gauze strip is at least brought onto the posterior end of the inferior or middle turbinate. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All outpatients with epigastric discomfort (non-ulcer dyspepsia), aged 18-65 years are eligibility for this study.
Key exclusion criteria (2 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 |
|---|---|---|
| Double pledget nasal anesthesia (DPNA)Also: A piece of a 10 X 10 cm Kendall gauze square (Eagle Highland Pharmacy,Indiana, USA) is cut into 4 right-angled triangular gauze strips., Two right-angled triangular gauze strip are used in DPNABy using a transnasal endoscope as a guide and a biopsy forceps, two gauze strips soaked with decongestant and anesthesia will be delivered to the middle meatus followed by the inferior meatus under real-time transnasal endoscopic guidance. | Device | Double pledget nasal anesthesia |
| Single pledget nasal anesthesia (SPNA)Also: A piece of a 10 X 10 cm Kendall gauze square (Eagle Highland Pharmacy,Indiana, USA) is cut into 4 right-angled triangular gauze strips., Only one right-angled triangular gauze strip is used in DPNA.Another randomized group of patients will also receive endoscopic-guided gauze pledgetting using a transnasal endoscope as a guide and a biopsy forceps. One gauze strip soaked with decongestant and anesthesia will be delivered to either the middle meatus or inferior meatus determined by anterior rhinoscopy. | Device | Single pledget nasal anesthesia |
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 within 15 minutes 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 26 Jun 2013.
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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 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 Double pledget nasal anesthesia (DPNA) and Single pledget nasal anesthesia (SPNA) in people with Anesthesia and Epistaxis, 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 1 inclusion and 2 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 26 Jun 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 26 Jun 2013; AzTrials last refreshed its copy on 2 Nov 2026.