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

JRCT ID: jRCTs072240042

Registered date:29/07/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients eligible for N2O inhalation sedation
• Date of first enrollment: 29/07/2024
• Target sample size: 60
• Study type: Interventional
• Intervention(s): N2O inhalation using NHF

Outcome(s)

Primary Outcome

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

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Magata Nobuaki
• Secondary Sponsor: Fisher & Paykel Healthcare Limited