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NCT01785173
A Randomized Study Comparing Endoscopic-guided Gauze Pledgetting and Cotton-tipped Applicator Packing for Nasal Anesthesia Before Transnasal Endoscopy
NA trial testing Endoscopic-guided gauze pledgetting in Methods of Nasal Anesthesia Before Transnasal Endoscopy in 242 participants. Status unknown.
1 April 2013
Quick facts
| Lead sponsor | Buddhist Tzu Chi General Hospital |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 242 |
| Start date | 1 October 2012 |
| Primary completion | 1 April 2013 |
| Estimated completion | 1 April 2013 |
| Sites | 1 location across Taiwan |
Drugs / interventions tested
- Endoscopic-guided gauze pledgetting
- Cotton-tipped applicator gauze pledgetting
Conditions studied
- Methods of Nasal Anesthesia Before Transnasal Endoscopy — all drugs for Methods of Nasal Anesthesia Before Transnasal Endoscopy →
- Side Effects of Transnasal Endoscopy — all drugs for Side Effects of Transnasal Endoscopy →
- Patient's Tolerance to Transnasal Endoscopy — all drugs for Patient's Tolerance to Transnasal Endoscopy →
Sponsor
Buddhist Tzu Chi General Hospital
Who can join
Adults 18 to 65, any sex, with Methods of Nasal Anesthesia Before Transnasal Endoscopy or Side Effects of Transnasal Endoscopy. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
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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-t
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01785173
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01785173 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Buddhist Tzu Chi General Hospital
- Last refreshed: 6 February 2013
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01785173.
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