Study of the effect of intranasal pressure measurement on intravenous sedation

JRCT ID: jRCTs032210050

Registered date:23/04/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Upper airway obstruction
• Date of first enrollment: 23/04/2021
• Target sample size: 52
• Study type: Interventional

Intervention(s)

Intervention group: Perform sedation adjustment with reference to the data from the type 3 portable sleep apnea monitor.
Non-intervention group: Perform sedation adjustment without reference to the data from the type 3 portable sleep apnea monitor.

Outcome(s)

• Primary Outcome: Abnormal Breathing Index (Apnea): ABI-A
• Secondary Outcome: Data from type 3 portable sleep apnea monitor, resurt of sleep study and questionnaire, medical informations, resurt of EEG recording and vital signs recording, anesthesia records, data from various monitors

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Male

Include criteria

1) Patients undergoing dental treatment under intravenous sedation.
2) Male over 20 years old
3) BMI, over 18.5 under 25
4) Patients whose preliminary sleep test result was less than AHI 10.0 times / hr
5) Patients who are healthy, or have mild systemic disease
6) Patients who agree to participate in this study

Exclude criteria

1) Patients who are not indicated for IVS
2) Patients who have congnitive and sensor impairment
3) Patients who judged to be ineligible fot this study by the doctor
4) Patients who don't agree to participate in this study

Related Information

• Primary Sponsor: Kohzuka Yuuya