Clinical trial NCT06205680: Soft Mist Nasal Administration Device for Topical Anaesthesia of the Nasal Cavity
Official title: Soft Mist Nasal Administration Device for Topical Anaesthesia of the Nasal Cavity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Local
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2024-01-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Participants are not randomized. A randomization (paper) strategy will be applied to determine which drug will be applied in which nostril
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Age between 18-60 years
* Lean body weight \>= 50 kg
* ASA physical status 1

Exclusion Criteria:

* 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

Primary outcomes:
measure: Level of anesthesia
timeFrame: on day of intervention
Secondary outcomes:
measure: Use of the NAA
timeFrame: on day of intervention
measure: Comfort level of NAA
timeFrame: on day of intervention
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
Study officials:
affiliation: Radboud University Medical Center (Radboudumc)
name: Hielke Markerink
role: STUDY_DIRECTOR
affiliation: Radboud University Medical Center (Radboudumc)
name: Geerf-Jan van Geffen
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Center (Radboudumc)
name: Jörgen Bruhn
role: STUDY_CHAIR
References: