Anesthesia, LocalNCT06205680
Soft Mist Nasal Administration Device for Topical Anaesthesia of the Nasal Cavity
A study testing NAA for topical anaesthesia of the nasal cavity in people with Anesthesia, Local, run by Radboud University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- NAA for topical anaesthesia of the nasal cavity
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Dec 2024to 15 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18-60 years
- Lean body weight >= 50 kg
- ASA physical status 1
Who cannot join
- Inability to cooperate
- History of hepatic, renal and coagulation diseases,
- Respiratory tract pathology
- Obstruction of the nasal passage
- Chronic rhinitis
- Chronic sinusitis
Show all 9Show fewer
- Pregnancy
- Allergy to amide type of local anaesthetics
- No written informed consent by subject
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- NAA for topical anaesthesia of the nasal cavity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAA for topical anaesthesia of the nasal cavityDevice
NAA for topical anaesthesia of the nasal cavity
| Study group | Role | What they receive |
|---|---|---|
| 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%). Receives: 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%). Receives: Device: NAA for topical anaesthesia of the nasal cavity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: on day of intervention
Secondary outcomes (2)
Use of the NAA
The convenience of using the NAA, reported by using a questionnaire.
Measured: on day of intervention
Comfort level of NAA
Studying the level of comfort of NAA for the patient, reported by using a questionnaire.
Measured: on day of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start15 Dec 2024
- Primary completion15 Apr 2025
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Participants are not randomized. A randomization (paper) strategy will be applied to determine which drug will be applied in which nostril
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hielke Markerink, Study director, Radboud University Medical Center (Radboudumc)Geerf-Jan van Geffen, Principal investigator, Radboud University Medical Center (Radboudumc)Jörgen Bruhn, Study chair, Radboud University Medical Center (Radboudumc)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205680
- Sponsor's protocol ID
- CT1 NAA lido
- Status last verified
- Apr 2025
- First submitted
- 27 Dec 2023
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soft Mist Nasal Administration Device for Topical Anaesthesia of the Nasal Cavity
- ClinicalTrials.gov ID
- NCT06205680
- Acronym / sponsor ID
- CT1 NAA lido
- Conditions
- Anesthesia, Local
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 16 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Participants are not randomized. A randomization (paper) strategy will be applied to determine which drug will be applied in which nostril
| Arm | Type | Receives |
|---|---|---|
| NAA with Lidocaine | Experimental | Device: NAA for topical anaesthesia of the nasal cavityOne 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% | Experimental | Device: NAA for topical anaesthesia of the nasal cavityOne 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%). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18-60 years
- Lean body weight >= 50 kg
- ASA physical status 1
Key exclusion criteria (9 listed)
- Inability to cooperate
- History of hepatic, renal and coagulation diseases,
- Respiratory tract pathology
- Obstruction of the nasal passage
- Chronic rhinitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NAA for topical anaesthesia of the nasal cavityNAA for topical anaesthesia of the nasal cavity | Device | NAA with Lidocaine, NAA with NaCl 0,9% |
Primary outcome
Level of anesthesia
Time frame: 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.
2 secondary outcomes
Use of the NAA
Time frame: on day of intervention
Comfort level of NAA
Time frame: on day of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hielke Markerink study director
Radboud University Medical Center (Radboudumc)
Geerf-Jan van Geffen principal investigator
Radboud University Medical Center (Radboudumc)
Jörgen Bruhn study chair
Radboud University Medical Center (Radboudumc)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NAA for topical anaesthesia of the nasal cavity in people with Anesthesia, Local, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of anesthesia (time frame: on day of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.