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

Not Applicable

Completed

• Conditions: Anesthesia, Local
• Interventions: Device: NAA for topical anaesthesia of the nasal cavity

• Registration Number: NCT06205680
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-27
• Study First Submitted QC: 2024-01-12
• Study First Posted: 2024-01-16
• Study Start: 2024-12-15
• Status Verified: 2025-04
• Primary Completion: 2025-04-15
• Study Completion: 2025-04-15
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NAA with Lidocaine	NAA for topical anaesthesia of the nasal cavity	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%	NAA for topical anaesthesia of the nasal cavity	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%).

Primary Outcome Measures

Name	Time	Method
Level of anesthesia	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.

Secondary Outcome Measures

Name	Time	Method
Use of the NAA	on day of intervention	The convenience of using the NAA, reported by using a questionnaire.
Comfort level of NAA	on day of intervention	Studying the level of comfort of NAA for the patient, reported by using a questionnaire.

Trial Locations

Locations (1)

Radboudumc; 🇳🇱 Nijmegen, Netherlands