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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Buddhist Tzu Chi General Hospital
Sponsor:
Information provided by (Responsible Party):
Chi-Tan Hu, Buddhist Tzu Chi General Hospital
ClinicalTrials.gov Identifier:
NCT01785173
First received: February 5, 2013
Last updated: February 6, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Methods of Nasal Anesthesia Before Transnasal Endoscopy
Side Effects of Transnasal Endoscopy
Patient's Tolerance to Transnasal Endoscopy
Procedure: Endoscopic-guided gauze pledgetting
Procedure: Cotton-tipped applicator gauze pledgetting

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomized Study Comparing Endoscopic-guided Gauze Pledgetting and Cotton-tipped Applicator Packing for Nasal Anesthesia Before Transnasal Endoscopy

Resource links provided by NLM:


Further study details as provided by Buddhist Tzu Chi General Hospital:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 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. ] [ Designated as safety issue: Yes ]

    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.



Estimated Enrollment: 242
Study Start Date: October 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Procedure: 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.
Active Comparator: 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.
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.

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01785173

Contacts
Contact: Chi-Tan Hu, MD, PhD +886933995773 chitan.hu@msa.hinet.net

Locations
Taiwan
Buddhist Tzu Chi Hospital Recruiting
Hualien City, Hualien county, Taiwan, 970
Contact: Chi-Tan Hu, MD, PhD    +886933995773    chitan.hu@msa.hinet.net   
Sponsors and Collaborators
Buddhist Tzu Chi General Hospital
Investigators
Principal Investigator: Chi-Tan Hu, MD, PhD Budhist Tzu Chi Hospital and Tzu Chi University
  More Information

No publications provided

Responsible Party: Chi-Tan Hu, Chief, Division of Gastroenterology, Buddhist Tzu Chi General Hospital, Buddhist Tzu Chi General Hospital
ClinicalTrials.gov Identifier: NCT01785173     History of Changes
Other Study ID Numbers: IRB101-85
Study First Received: February 5, 2013
Last Updated: February 6, 2013
Health Authority: Taiwan: Research Ethics Committee

Keywords provided by Buddhist Tzu Chi General Hospital:
Endoscopes
Esophago-gastro-duodenoscopy
Transnasal endoscopy
Nasal anesthesia

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014