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[A Study of Utility and Safety of 30% N2O Inhalation Sedation Applied with Nasal High Flow]

A Study of Utility and Safety of 30% N2O Inhalation Sedation Applied with Nasal High Flow ~Single-center, randomized, open-label, group-comparative study~.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs072240042
Enrollment
60
Registered
2024-07-29
Start date
2024-07-29
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients eligible for N2O inhalation sedation

Interventions

N2O inhalation using NHF

Sponsors

Magata Nobuaki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients who visit Department of Special Care Dentistry and whose attending physician determines that N2O inhalation sedation is suitable. 2.Patients undergoing dental treatment other than tooth extraction, which is expected to take approximately 45 to 60 minutes. 3.Adult patients who are 18 years of age or older at the time of obtaining consent 4.Sex:No questions asked 5.Outpatient only 6.Patients who have received sufficient explanation to participate in this study, and who have given their voluntary written consent based on sufficient understanding.

Exclusion criteria

Exclusion criteria: 1.Patients receiving continuous administration of oxygen through a nasal cannula (home oxygen therapy) 2.Patients who cannot breathe through the nose 3.Patients with serious respiratory and circulatory system diseases 4.Patients undergoing bronchial asthma attacks or with a history of severe bronchial asthma 5.Patients with vitamin B12 deficiency 6.Patients with hematopoietic dysfunction 7.Patients with a closed cavity in the body, such as ductal obstruction, pneumothorax, intestinal obstruction, pneumoencephalopathy, etc. 8.Patients after eye surgery inwhom the gases used for tamponade (perfluoropropane, sulfur hexafluoride, etc.) is present in the vitreous. 9.Pregnant woman 10. patients judged by the principal investigator to be unsuitable as research subjects

Design outcomes

Primary

MeasureTime frame
1.Presence or absence of nausea and vomiting 2.Presence or absence of pain during periodontal pocket examination

Secondary

MeasureTime frame
Sedation due to N2O and presence or absence of symptoms and changes in breathing rate are continuously measured and evaluated using AIRVO3. (Indirect indicator of carbon dioxide accumulation) 1.Feeling warm 2.Numbness in limbs 3.Numbness of the tongue and lips 4. Abnormal sense of hearing 5. Comfortable feeling 6. Feeling depressed 7. Eyes closed 8.Feeling uncomfortable

Contacts

Public ContactNobuaki Magata

Nagasaki University Hospital

magata@nagasaki-u.ac.jp+81-958197714

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026