Double Versus Single Pledget Method of Nasal Anesthesia for Transnasal Endoscopy: A Randomized Prospective Control Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 212
- 试验地点
- 2
- 主要终点
- The primary outcome measures are tolerability profiles on a validated visual analogue scale
研究概览
简要总结
Unsedated ultrathin transnasal esophago-gastro-duodenoscopy (UT-EGD), in comparison with conventional peroral EGD (P-EGD) has been shown to be more tolerable, safer, cost-effective and time-efficient. The investigators and in other studies have showed that nasal pledgetting (or commonly termed nasal packing) is better than nasal spray in terms of patient tolerance and visual capacity. Although pledgetting method to a selected meatus can achieve better decongestion effect, epistaxis and nasal pain in some patients are still frustrating to endoscopists.
The investigator has proposed a novel meatus scoring scale to evaluate nasal insertability by anterior rhinoscopy using a transnasal endoscope. The investigator also suggest endoscopic-guided gauze pledgetting can provide precise nasal anesthesia, thereby reducing trauma/bleeding in the nasal cavity and increasing patient tolerance during transnasal endoscopy. Endoscopic guidance to deliver a gauze strip can confirm delivering it to at least the posterior end of a turbinate. We hypothesize that by using endoscopic-guided method, gauze pledgetting to both the inferior nasal meatus (INM) and middle nasal meatus (MNM) simultaneously is more tolerable than only gauze pledgetting to a single meatus.
详细描述
Nasal anesthesia is the rate-limiting step for a well tolerable unsedated transnasal esophago-gastro-duodenoscopy (UT-EGD) procedure. The investigator has proposed 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. The initial idea of EGGP is to anesthetize only one single selected meatus. To compare patient tolerance, safety and adverse events between double pledget (DPNA, i.e. INM and MNM) versus single pledget (SPNA, i.e. INM or MNM) methods of nasal anesthesia, the investigator is going to conduct a prospective randomized-controlled trial. The rationale for using double pledget is threefold: (1) the middle meatus is bounded by the INT and MNT; (2) the inserting and exserting meatuses may be different; (3) erective spongy tissue is mainly distributed in the inferior and middle turbinates and the nasal septum. Therefore, the primary objective of this study is to evaluate whether DPNA is more tolerable and safer than DPNA before UT-EGD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All outpatients with epigastric discomfort (non-ulcer dyspepsia), aged 18-65 years are eligibility for this study.
排除标准
- •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.
结局指标
主要结局
The primary outcome measures are tolerability profiles on a validated visual analogue scale
时间窗: 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.
次要结局
- Secondary outcome measures evaluate the side effects of nasal anesthesia(The immediate secondary outcome measures will be evaluated by questionnaires immediately after UT-EGD within 15 minutes and the delayed secondary outcome measures will be evaluated by otolaryngologists within two weeks after UT-EGD.)
研究者
Chi-Tan Hu
Chief, Division of Gastroenterology, Buddhist Tzu Chi General Hospital
Buddhist Tzu Chi General Hospital