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

NCT06205680 | Completed

• 1 other identifier: CT1 NAA lido
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia, Local

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Use of the NAA

  on day of intervention

• Comfort level of NAA

  on day of intervention

Study Arms (2)

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%).

Device: NAA for topical anaesthesia of the nasal cavity

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%).

Device: NAA for topical anaesthesia of the nasal cavity

Interventions

NAA for topical anaesthesia of the nasal cavity DEVICE

NAA for topical anaesthesia of the nasal cavity

NAA with Lidocaine; NAA with NaCl 0,9%

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, 6533 HA, Netherlands

Location

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are not randomized. A randomization (paper) strategy will be applied to determine which drug will be applied in which nostril

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: January 16, 2024
• Study Start: December 15, 2024
• Primary Completion: April 15, 2025
• Study Completion: April 15, 2025
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)