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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NAA with Lidocaine | Experimental | 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%). |
|
| NAA with NaCl 0,9% | Experimental | 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%). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NAA for topical anaesthesia of the nasal cavity | Device | NAA for topical anaesthesia of the nasal cavity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Level of anesthesia | Studying the level of anesthesia of the nasal mucosa as evaluated and demonstrated with successful awake nasal instrumentation with minimal discomfort for the subject. | on day of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Use of the NAA | The convenience of using the NAA, reported by using a questionnaire. | on day of intervention |
| Comfort level of NAA | Studying the level of comfort of NAA for the patient, reported by using a questionnaire. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hielke Markerink | Radboud University Medical Center (Radboudumc) | Study Director |
| Geerf-Jan van Geffen | Radboud University Medical Center (Radboudumc) | Principal Investigator |
| Jörgen Bruhn | Radboud University Medical Center (Radboudumc) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboudumc | Nijmegen | 6533 HA | Netherlands |
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Participants are not randomized. A randomization (paper) strategy will be applied to determine which drug will be applied in which nostril
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| on day of intervention |