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Double Versus Single Pledget Nasal Anesthesia for Transnasal Endoscopy

Primary Purpose

Anesthesia, Epistaxis

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Double pledget nasal anesthesia (DPNA)
Single pledget nasal anesthesia (SPNA)
Sponsored by
Buddhist Tzu Chi General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anesthesia focused on measuring Nasal anesthesia, endoscopes, transnasal endoscopy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

All outpatients with epigastric discomfort (non-ulcer dyspepsia), aged 18-65 years are eligibility for this study.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Buddhist Tzu Chi HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Double pledget nasal anesthesia

Single pledget nasal anesthesia

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 7, 2013
Last Updated
June 22, 2013
Sponsor
Buddhist Tzu Chi General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01886768
Brief Title
Double Versus Single Pledget Nasal Anesthesia for Transnasal Endoscopy
Official Title
Double Versus Single Pledget Method of Nasal Anesthesia for Transnasal Endoscopy: A Randomized Prospective Control Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
February 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Buddhist Tzu Chi General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Epistaxis
Keywords
Nasal anesthesia, endoscopes, transnasal endoscopy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
212 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Double pledget nasal anesthesia
Arm Type
Experimental
Arm Description
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.
Arm Title
Single pledget nasal anesthesia
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Double pledget nasal anesthesia (DPNA)
Other Intervention Name(s)
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
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Single pledget nasal anesthesia (SPNA)
Other Intervention Name(s)
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.
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary outcome measures are tolerability profiles on a validated visual analogue scale
Description
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.
Time Frame
Immediately after transnasal endoscopy up to all questionnaires answered (about 15 minutes)
Secondary Outcome Measure Information:
Title
Secondary outcome measures evaluate the side effects of nasal anesthesia
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All outpatients with epigastric discomfort (non-ulcer dyspepsia), aged 18-65 years are eligibility for this study. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chi-Tan Hu, MD, PhD
Phone
+886933995773
Email
chitan.hu@msa.hinet.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chi-Tan Hu
Organizational Affiliation
Budhist Tzu Chi Hospital and Tzu Chi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Buddhist Tzu Chi Hospital
City
Hualien City
State/Province
Hualien county
ZIP/Postal Code
970
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chi-Tan Hu, MD, PhD
Phone
+886933995773
Email
chitan.hu@msa.hinet.net

12. IPD Sharing Statement

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Double Versus Single Pledget Nasal Anesthesia for Transnasal Endoscopy

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