Endoscopic-guided Versus Cotton-tipped Applicator Gauze Pledgetting for Nasal Anesthesia Before Transnasal Endoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-04-30

Brief Summary

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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.

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Detailed Description

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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

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Methods of Nasal Anesthesia Before Transnasal Endoscopy Side Effects of Transnasal Endoscopy Patient's Tolerance to Transnasal Endoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Endoscopic-guided gauze pledgetting

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.

Group Type EXPERIMENTAL

Endoscopic-guided gauze pledgetting

Intervention Type PROCEDURE

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 pledgetting

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.

Group Type ACTIVE_COMPARATOR

Cotton-tipped applicator gauze pledgetting

Intervention Type PROCEDURE

In contrast to the endoscopic-guided, forceps-delivering method, a gauze strip is delivered to a selected meatus by a cotton-tipped applicator.

Interventions

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Endoscopic-guided gauze pledgetting

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.

Intervention Type PROCEDURE

Cotton-tipped applicator gauze pledgetting

In contrast to the endoscopic-guided, forceps-delivering method, a gauze strip is delivered to a selected meatus by a cotton-tipped applicator.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No