Soft Mist Nasal Administration Device for Topical Anaesthesia of the Nasal Cavity

Anesthesia, Local Clinical Trial

Official title:

Soft Mist Nasal Administration Device for Topical Anaesthesia of the Nasal Cavity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06205680
• Other study ID #: CT1 NAA lido
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: August 1, 2024

Study information

• Verified date: December 2023
• Source: Radboud University Medical Center
• Contact: Hielke Markerink
• Phone: +31 (0)24 3655 755
• Email: hielke.markerink[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: August 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Local

Intervention

Device:
• NAA for topical anaesthesia of the nasal cavity
NAA for topical anaesthesia of the nasal cavity

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Use of the NAA	The convenience of using the NAA, reported by using a questionnaire.	on day of intervention
Secondary	Comfort level of NAA	Studying the level of comfort of NAA for the patient, reported by using a questionnaire.	on day of intervention