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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, Local
• Intervention / Treatment: Device: NAA for topical anaesthesia of the nasal cavity

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Nijmegen, Netherlands, 6533 HA
    • Radboudumc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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%).	Device: NAA for topical anaesthesia of the nasal cavity; NAA for topical anaesthesia of the nasal cavity
Experimental: 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%).	Device: NAA for topical anaesthesia of the nasal cavity; NAA for topical anaesthesia of the nasal cavity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	on day of intervention

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Investigators: Study Director: Hielke Markerink, Radboud University Medical Center (Radboudumc); Principal Investigator: Geerf-Jan van Geffen, Radboud University Medical Center (Radboudumc); Study Chair: Jörgen Bruhn, Radboud University Medical Center (Radboudumc)

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2024
• Primary Completion (Actual): April 15, 2025
• Study Completion (Actual): April 15, 2025

Study Registration Dates

• First Submitted: December 27, 2023
• First Submitted That Met QC Criteria: January 12, 2024
• First Posted (Actual): January 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2025
• Last Update Submitted That Met QC Criteria: April 24, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: CT1 NAA lido

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No