Dental Anesthesiology
Conditions
Interventions
This study is a Cohot study in which the same subjects were sedated and each parameter was measured before and after the use of a nasopharyngeal tube.
Sponsors
KANAGAWA DENTAL UNIVERSITY
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy adults (1 or 2 in the American Society of Anaesthesiologists' Classification of Systemic Conditions (ASA-PS classification))
Exclusion criteria
Exclusion criteria: 1) If there is habitual mouth breathing or if the patient is reported to be prone to epistaxis 2) Inflammation or tumour of the nasal cavity, suspected skull base fracture 3) If there is a history of chronic obstructive pulmonary disease (COPD) 4) If allergic to any of the drugs used (Propofol, Midazolam, Flumazenil) 5) If the EEG cannot be measured accurately, e.g. history of epilepsy 6) If the patient is taking antithrombotic or anticoagulant medication 7) If the patient is unable to comply with the no eating or drinking times (no food: 6 hours before the procedure No water: 3 hours before the procedure) 8) If consent to participate in the study cannot be obtained 9) If the principal investigator considers the patient to be unsuitable for participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Evaluation of respiration and oxygenation: 1. The number of apneas (pAHI), degree of snoring, peripheral vascular blood flow (PAT amplitude), and arousal state are continuously recorded using the WatchPat 300 (sleep evaluation device). 2. Exhaled end-expiratory partial pressure of carbon dioxide (EtCO2) and capnogram are recorded by capnography. EtCO2 is recorded every 15 minutes in the anesthesia record. Oxygen saturation is measured by measuring SpO2 using a pulse oximeter. 2) Evaluation of tissue blood flow: 1. Brain tissue blood flow and oxygenation caused by changes in respiration during sedation will be evaluated using NIRO 200nx (Near Infrared Spectroscopy) and recorded continuously. 3) Evaluation of stress: 1. The effects of changes in respiration during sedation on autonomic nervous system activity will be evaluated using my Beat (heart rate variability analyzer) and recorded continuously. 2. Cortisol, sIgA, sIgG, and amylase will be measured using the SOMA CUBE Reader (salivary stress marker analyzer) to evaluate the effects on stress. Saliva samples are collected 2 minutes prior to body position change. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Record the subject's basic information: Age, gender, height, weight, current medical history, medical history, medication status, amount of mouth opening/ distance between mussel hyoid bones/ distance between hyoid bones thyroid cartilage, tongue size, presence of enlarged tonsils, number of remaining teeth, presence of cervical backbending restriction, frequency of habitual snoring. 2) Vital signs during and before and after sedation: Blood pressure, pulse rate, heart rate, SpO2, respiratory rate 3) Assessment of sedation level: Evaluated by electroencephalogram monitoring (BIS), OAA/S score, and the definition of sedation depth in the sedation guidelines of the American Society of Anesthesiologists. 4) Subject's Impression: After sedation, the subject's satisfaction with sedation and discomfort related to the use of the nasopharyngeal tube will be evaluated using the Visual Analogue Scale (VAS). | — |
Countries
Japan
Contacts
Public ContactHIDETAKA KURODA
KANAGAWA DENTAL UNIVERSITY Department of Anesthesiology, Division of Dental Anesthesiology
Outcome results
None listed