Soft Mist Nasal Administration Device for Topical Anaesthesia of the Nasal Cavity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Level of anesthesia
研究概览
简要总结
Rationale:
Effective and fast topical anesthesia of the nasal mucosa is of paramount importance for nasal instrumentation like nasal fiberoptic procedures, awake nasal fiberoptic intubation and placement of nasogastric tubes. Conventional topical anesthesia for the nasal mucosa is often patchy and not always effective. The investigators hypothesize that topical anesthesia of the nasal mucosa with the nasal atomizer adapter (NAA) provides good to excellent nasal topical anesthesia with high patient comfort.
Objective: In this study the NAA will be used for nasal topical anesthesia. The investigators will evaluate complete anesthesia of the nasal mucosa for nasal instrumentation, the use of the NAA and the comfort level for the subjects.
Study design: Interventional study.
Study population: 20 healthy human volunteers, ASA 1, 18-60 years old.
Intervention: Lidocaine 2% will be applied intranasally with the NAA before nasal instrumentation. On completion of the procedure the participant and the researcher will be asked to complete a feedback form.
Main study parameters/endpoints:
Studying the level of anesthesia of the nasal mucosa as evaluated and demonstrated with successful awake nasal instrumentation with minimal discomfort for the subject.
Nature and extent of the burden and risks associated with participation:
Risk management on the nasal atomizer adapter (NAA) shows that all user risks are mitigated and no residual risks remain for the use of the device. Testing of the device and the application of the device in daily practice has no additional risks than the present technique of performing topical anaesthesia of the nasal mucosa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18-60 years
- •Lean body weight >= 50 kg
- •ASA physical status 1
排除标准
- •Inability to cooperate
- •History of hepatic, renal and coagulation diseases,
- •Respiratory tract pathology
- •Obstruction of the nasal passage
- •Chronic rhinitis
- •Chronic sinusitis
- •Pregnancy
- •Allergy to amide type of local anaesthetics
- •No written informed consent by subject
研究组 & 干预措施
NAA with Lidocaine
One 1 ml syringes with lidocaine 2 % will be prepared and connected to the NAA device. The device will be placed in front of a nostril and the subject is asked not to breath until 0,5 ml of lidocaine has been administered. The lidocaine will be sprayed by the attending anaesthesiologist. After a waiting period of 2 minutes another 0,5 ml of lidocaine will be administered (= total of 1 ml lidocaine 2%).
干预措施: NAA for topical anaesthesia of the nasal cavity (Device)
NAA with NaCl 0,9%
One 1 ml syringes with NaCl 0,9 % will be prepared and connected to the NAA device.
The device will be placed in front of the other nostril and the subject is asked not to breath until 0,5 ml of NaCl has been administered. The NaCl will be sprayed by the attending anaesthesiologist. After a waiting period of 2 minutes another 0,5 ml of NaCl will be administered (= total of 1 ml NaCl 0,9%).
干预措施: NAA for topical anaesthesia of the nasal cavity (Device)
结局指标
主要结局
Level of anesthesia
时间窗: on day of intervention
Studying the level of anesthesia of the nasal mucosa as evaluated and demonstrated with successful awake nasal instrumentation with minimal discomfort for the subject.
次要结局
- Use of the NAA(on day of intervention)
- Comfort level of NAA(on day of intervention)