Double Versus Single Pledget Method of Nasal Anesthesia for Transnasal Endoscopy: A Randomized Prospective Control Study

Double Versus Single Pledget Nasal Anesthesia for Transnasal Endoscopy

Sponsors

Lead sponsor: Buddhist Tzu Chi General Hospital

Source Buddhist Tzu Chi General Hospital
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.

Overall Status Unknown status
Start Date September 2012
Completion Date February 2014
Primary Completion Date February 2014
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
The primary outcome measures are tolerability profiles on a validated visual analogue scale Immediately after transnasal endoscopy up to all questionnaires answered (about 15 minutes)
Secondary Outcome
Measure Time Frame
Secondary outcome measures evaluate the side effects of nasal anesthesia 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.
Enrollment 212
Condition
Intervention

Intervention type: Device

Intervention name: Double pledget nasal anesthesia (DPNA)

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.

Arm group label: Double pledget nasal anesthesia

Intervention type: Device

Intervention name: Single pledget nasal anesthesia (SPNA)

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.

Arm group label: Single pledget nasal anesthesia

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.

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Chi-Tan Hu Principal Investigator Budhist Tzu Chi Hospital and Tzu Chi University
Overall Contact

Last name: Chi-Tan Hu, MD, PhD

Phone: +886933995773

Email: [email protected]

Location
facility status contact
Buddhist Tzu Chi Hospital Recruiting Chi-Tan Hu, MD, PhD +886933995773 [email protected]
Location Countries

Taiwan

Verification Date

June 2013

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Buddhist Tzu Chi General Hospital

Investigator full name: Chi-Tan Hu

Investigator title: Chief, Division of Gastroenterology, Buddhist Tzu Chi General Hospital

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Double pledget nasal anesthesia

Arm group type: Experimental

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 group label: Single pledget nasal anesthesia

Arm group type: Active Comparator

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.

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov