A Randomized Study Comparing Endoscopic-guided Gauze Pledgetting and Cotton-tipped Applicator Packing for Nasal Anesthesia Before Transnasal Endoscopy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Methods of Nasal Anesthesia Before Transnasal Endoscopy
- Sponsor
- Buddhist Tzu Chi General Hospital
- Enrollment
- 242
- Locations
- 1
- Primary Endpoint
- The primary outcome measures are tolerability profiles on a validated visual analogue scale
- Last Updated
- 13 years ago
Overview
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.
Investigators
Chi-Tan Hu
Chief, Division of Gastroenterology, Buddhist Tzu Chi General Hospital
Buddhist Tzu Chi General Hospital
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.
Outcomes
Primary Outcomes
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)
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 Outcomes
- Secondary outcome measures evaluate the side effects of nasal anesthesia(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.)