Clinical trial NCT01785173: Endoscopic-guided Versus Cotton-tipped Applicator Gauze Pledgetting for Nasal Anesthesia Before Transnasal Endoscopy
Official title: A Randomized Study Comparing Endoscopic-guided Gauze Pledgetting and Cotton-tipped Applicator Packing for Nasal Anesthesia Before Transnasal Endoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Buddhist Tzu Chi General Hospital
Sponsor class: OTHER
First posted: 2013-02-07
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.

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.

Primary outcomes:
measure: The primary outcome measures are tolerability proﬁles on a validated visual analogue scale
timeFrame: Immediately after transnasal endoscopy up to all questionnaires answered (about 15 minutes)
Secondary outcomes:
measure: Secondary outcome measures evaluate the side effects of nasal anesthesia
timeFrame: 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.
Other outcomes:
Locations:
city: Hualien City
country: Taiwan
facility: Buddhist Tzu Chi Hospital
state: Hualien county
Study officials:
affiliation: Budhist Tzu Chi Hospital and Tzu Chi University
name: Chi-Tan Hu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: